Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006947', 'term': 'Hyperkalemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568789', 'term': 'patiromer'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Diamond_Information@viforpharma.com', 'phone': '+41 588 518 000', 'title': 'DIAMOND Clinical Study Team', 'organization': 'Vifor Pharma, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'eventGroups': [{'id': 'EG000', 'title': 'Patiromer', 'description': 'Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).', 'otherNumAtRisk': 439, 'deathsNumAtRisk': 439, 'otherNumAffected': 320, 'seriousNumAtRisk': 439, 'deathsNumAffected': 24, 'seriousNumAffected': 54}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).', 'otherNumAtRisk': 439, 'deathsNumAtRisk': 439, 'otherNumAffected': 325, 'seriousNumAtRisk': 439, 'deathsNumAffected': 18, 'seriousNumAffected': 58}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 335, 'numAffected': 197}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 412, 'numAffected': 238}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 75, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 53, 'numAffected': 47}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': "Pancoast's tumour", 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Plasmacytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Traumatic intracranial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vascular procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ultrasound pancreas abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vocal cord dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vascular encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Intestinal pseudo-obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Inflammatory bowel disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Muscle atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Serum K+ Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patiromer', 'description': 'Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.029', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.127', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.097', 'ciLowerLimit': '-0.128', 'ciUpperLimit': '-0.067', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.015', 'groupDescription': 'Difference in adjusted mean changes (SE)', 'statisticalMethod': 'Mixed model for repeated measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'description': 'Adjusted mean changes in serum K+ from Baseline.', 'unitOfMeasure': 'Milliequivalents Per Liter (mEq/l)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patiromer', 'description': 'Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.06'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.06'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.11'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.13'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.12'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.18'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.17'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.24'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.22'}, {'value': '0.24', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '0.29'}]}]}, {'title': 'Week 54', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.27'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.35'}]}]}, {'title': 'Week 66', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '0.32'}, {'value': '0.34', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.42'}]}]}, {'title': 'Week 78', 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.40'}, {'value': '0.34', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.42'}]}]}, {'title': 'Week 90', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.44'}, {'value': '0.34', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.42'}]}]}], 'analyses': [{'pValue': '= 0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.87', 'pValueComment': 'Threshold for statistical significance = 0.05', 'groupDescription': 'Hazard Ratio patiromer vs placebo.\n\nThe HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.\n\nHR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1/Baseline to week 90', 'description': 'Cumulative incidence of the first event of hyperkalemia with a serum K+ value \\>5.5 mEq/l taking death as competing and calculated as CIF Estimates (95% CI) over time.\n\nAalen-Johansen estimators of the cumulative incidence function with death as a competing event.\n\nCIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patiromer', 'description': 'Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.07'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.05'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.11'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.08'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.15'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.14'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.19'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.18'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.23'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.21'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.28'}]}]}, {'title': 'Week 54', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.24'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.32'}]}]}, {'title': 'Week 66', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.29'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '0.33'}]}]}, {'title': 'Week 78', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.35'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.36'}]}]}, {'title': 'Week 90', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.35'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.36'}]}]}, {'title': 'Week 102', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.35'}, {'value': 'NA', 'comment': 'Not feasible to estimate the cumulative incidence at a time beyond the largest observed time', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '= 0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.87', 'pValueComment': 'Threshold for statistical significance = 0.05', 'groupDescription': 'Hazard Ratio patiromer vs placebo.\n\nThe HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.\n\nHR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1/Baseline to week 102', 'description': 'Cumulative incidence of the reduction of the MRA dose below target dose calculated as CIF Estimates (95% CI) over time.\n\nNote: The reduction below the MRA target dose must last for at least 14 days (orless if at the end of study) to confirm this endpoint.\n\nCIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Investigator-reported Events of Hyperkalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patiromer', 'description': 'Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}], 'classes': [{'categories': [{'measurements': [{'value': '82.38', 'groupId': 'OG000'}, {'value': '114.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Annualized event rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.658', 'ciLowerLimit': '0.534', 'ciUpperLimit': '0.81', 'groupDescription': 'NBMAC Annualized event RR patiromer vs placebo.\n\nNBMAC adjusted for geographical region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. Rate ratio less than 1 favors patiromer.\n\nNBMAC=Negative binomial model adjusted for covariates; RR=Rate Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate', 'statisticalMethod': 'Negative binomial model adjusted for cov', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'description': "Participant's follow-up is from the date of the first dose of randomized study medication up to the participant's end of study date or 24 Jun 2021, whichever comes first.\n\nAnnualized event rate per 100 subject-years= The total number of events for all subjects in the treatment group divided by the total subject-years of follow-up in that treatment group multiplied by 100.", 'unitOfMeasure': 'Ann. event rate per 100 subject-years', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hyperkalemia-related Hard Outcomes Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '878', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants randomized to patiromer or placebo arm.'}], 'classes': [{'title': 'CV death in Placebo Group First', 'categories': [{'measurements': [{'value': '3491', 'groupId': 'OG000'}]}]}, {'title': 'CV death in Patiromer Group First', 'categories': [{'measurements': [{'value': '4609', 'groupId': 'OG000'}]}]}, {'title': 'More CV hospitalizations in Placebo Group', 'categories': [{'measurements': [{'value': '4539', 'groupId': 'OG000'}]}]}, {'title': 'More CV hospitalizations in Patiromer Group', 'categories': [{'measurements': [{'value': '4178', 'groupId': 'OG000'}]}]}, {'title': 'MHTE with serum K+>6.5 in Placebo Group', 'categories': [{'measurements': [{'value': '419', 'groupId': 'OG000'}]}]}, {'title': 'MHTE with serum K+>6.5 in Patiromer Group', 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}]}]}, {'title': 'MHE with serum K+>6.0-6.5 in Placebo Group', 'categories': [{'measurements': [{'value': '4283', 'groupId': 'OG000'}]}]}, {'title': 'MHE with serum K+>6.0-6.5 in Patiromer Group', 'categories': [{'measurements': [{'value': '1446', 'groupId': 'OG000'}]}]}, {'title': 'MHE with serum K+>5.0-6.0 in Placebo Group', 'categories': [{'measurements': [{'value': '55633', 'groupId': 'OG000'}]}]}, {'title': 'MHE with serum K+>5.0-6.0 in Patiromer Group', 'categories': [{'measurements': [{'value': '34156', 'groupId': 'OG000'}]}]}, {'title': 'None of the above', 'categories': [{'measurements': [{'value': '79566', 'groupId': 'OG000'}]}]}, {'title': 'Total number of pairs', 'categories': [{'measurements': [{'value': '192721', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.526', 'ciLowerLimit': '1.231', 'ciUpperLimit': '1.906', 'groupDescription': 'Win ratio for composite.\n\nWin ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers.', 'statisticalMethod': 'Win Ratio', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.744', 'groupIds': ['OG000'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.914', 'ciLowerLimit': '0.526', 'ciUpperLimit': '1.578', 'groupDescription': 'Win ratio CV death and hospitalization.\n\nWin ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer.', 'statisticalMethod': 'Win Ratio', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'description': 'Analyzed using Win Ratio approach with the following hierarchical components:\n\n1. Time to CV death\n2. Total number of CV hospitalizations\n3. Total number of hyperkalemia toxicity events with serum K+ \\>6.5 mEq/l\n4. Total number of hyperkalemia events with serum K+ \\>6.0-6.5 mEq/l\n5. Total number of hyperkalemia events with serum K+ \\>5.0 mEq/l\n\nMHTE=More hyperkalemia toxicity events; MHE=More hyperkalemia events; CV=Cardiovascular', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'RAASi Use Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '878', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants randomized to patiromer or placebo arm.'}], 'classes': [{'title': 'Number of wins in Patiromer Group', 'categories': [{'measurements': [{'value': '62073', 'groupId': 'OG000'}]}]}, {'title': 'Number of wins in Placebo Group', 'categories': [{'measurements': [{'value': '49733', 'groupId': 'OG000'}]}]}, {'title': 'Number of ties', 'categories': [{'measurements': [{'value': '80915', 'groupId': 'OG000'}]}]}, {'title': 'Total number of pairs', 'categories': [{'measurements': [{'value': '192721', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '= 0.048', 'groupIds': ['OG000'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.248', 'ciLowerLimit': '1.003', 'ciUpperLimit': '1.564', 'groupDescription': 'Win ratio for composite.\n\nWin ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer.', 'statisticalMethod': 'Win Ratio', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'description': 'RAASi use score (0 to 8 points) analyzed using the Win Ratio approach for each pair of participants with the following additive components:\n\n1. All-cause death\n2. Occurrence of a CV hospitalization\n3. HF medication use and dose for i) an ACEi/ARB/ARNi, ii) a MRA, and iii) a beta-blocker\n\nEach participant in each comparison can have 0-8 points and all participants are compared using this score at the respective appropriate follow-up time point.\n\nRAASi=renin-angiotensin-aldosterone system inhibitor; ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor/neprilysin inhibitor; MRA=mineralocorticoid receptor antagonist.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patiromer', 'description': 'Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).\n\nmEq/l = Milliequivalents Per Liter'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).\n\nmEq/l = Milliequivalents Per Liter'}], 'periods': [{'title': 'Run-in Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1195'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '878'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '317'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomization Criterion #1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #1, #2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #1, #2 #4; AE; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #1, #3', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #1, #4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Crit #1, #4; Withdraw By Subject; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #1, #4; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #1; AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #1; AE; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #1; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #2, #3', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #2, #3, #4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #2, #4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #3', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #3, #4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criteria #3, #4; 2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #3; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #3; Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #4; AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #4; AE; 2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #3; Exceeded 12 Weeks Of Run In', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #4; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Criterion #4; 2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'AE (Adverse Event)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'AE; Withdrawal By Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'AE; Withdrawal By Subject; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'AE; 1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'AE; 2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'AE; Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '1 Wk After 3 Patiromer Packets/Day, sK+ >5.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal By Subject; Withdrawal Of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '2 Wks After Taking Min 0 Packet/Day, sK+ Is < 4.0 Meq/L', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal Of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Exceeded 12 Weeks Of Run In', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not treated with Patiromer during Run-in', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase (Overall Study)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}, {'groupId': 'FG001', 'numSubjects': '439'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '367'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Consent withdrawn by subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'End of study visit not completed/delayed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Early study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Treatment discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Delayed visit and insufficient study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': "Sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'From a total of 1642 screened participants, 1195 entered the Run-in Phase. The Run-in Phase Set includes participants who signed the informed consent and received at least 1 dose of patiromer during the Run-in Phase but were not eligible to be randomized. A total of 1168 participants received patiromer during Run-in Phase, and 878 of these participants were randomized to receive patiromer or placebo during the Treatment Phase'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '878', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patiromer', 'description': 'Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.\n\nThe starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '66.9', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '327', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '640', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '381', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '760', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Georgia', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-23', 'size': 1359118, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-25T11:56', 'hasProtocol': True}, {'date': '2021-11-24', 'size': 486489, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-25T11:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and 12 weeks Run-in Phase and a randomized withdrawal Blinded Treatment Phase.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2019-03-12', 'resultsFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-22', 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Serum K+ Levels From Baseline', 'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'description': 'Adjusted mean changes in serum K+ from Baseline.'}], 'secondaryOutcomes': [{'measure': 'CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time', 'timeFrame': 'From Day 1/Baseline to week 90', 'description': 'Cumulative incidence of the first event of hyperkalemia with a serum K+ value \\>5.5 mEq/l taking death as competing and calculated as CIF Estimates (95% CI) over time.\n\nAalen-Johansen estimators of the cumulative incidence function with death as a competing event.\n\nCIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter'}, {'measure': 'CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time', 'timeFrame': 'From Day 1/Baseline to week 102', 'description': 'Cumulative incidence of the reduction of the MRA dose below target dose calculated as CIF Estimates (95% CI) over time.\n\nNote: The reduction below the MRA target dose must last for at least 14 days (orless if at the end of study) to confirm this endpoint.\n\nCIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter'}, {'measure': 'Investigator-reported Events of Hyperkalemia', 'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'description': "Participant's follow-up is from the date of the first dose of randomized study medication up to the participant's end of study date or 24 Jun 2021, whichever comes first.\n\nAnnualized event rate per 100 subject-years= The total number of events for all subjects in the treatment group divided by the total subject-years of follow-up in that treatment group multiplied by 100."}, {'measure': 'Hyperkalemia-related Hard Outcomes Endpoints', 'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'description': 'Analyzed using Win Ratio approach with the following hierarchical components:\n\n1. Time to CV death\n2. Total number of CV hospitalizations\n3. Total number of hyperkalemia toxicity events with serum K+ \\>6.5 mEq/l\n4. Total number of hyperkalemia events with serum K+ \\>6.0-6.5 mEq/l\n5. Total number of hyperkalemia events with serum K+ \\>5.0 mEq/l\n\nMHTE=More hyperkalemia toxicity events; MHE=More hyperkalemia events; CV=Cardiovascular'}, {'measure': 'RAASi Use Score', 'timeFrame': 'Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo', 'description': 'RAASi use score (0 to 8 points) analyzed using the Win Ratio approach for each pair of participants with the following additive components:\n\n1. All-cause death\n2. Occurrence of a CV hospitalization\n3. HF medication use and dose for i) an ACEi/ARB/ARNi, ii) a MRA, and iii) a beta-blocker\n\nEach participant in each comparison can have 0-8 points and all participants are compared using this score at the respective appropriate follow-up time point.\n\nRAASi=renin-angiotensin-aldosterone system inhibitor; ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor/neprilysin inhibitor; MRA=mineralocorticoid receptor antagonist.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treatment of hyperkalemia', 'chronic kidney disease', 'hypertension', 'hyperkalemia', 'potassium', 'spironolactone', 'heart failure', 'Renin Angiotensin-Aldosterone System Inhibitor (RAASi)', 'RAASi', 'high potassium', 'eplerenone', 'reduced ejection fraction'], 'conditions': ['Hyperkalemia']}, 'referencesModule': {'references': [{'pmid': '39340493', 'type': 'DERIVED', 'citation': 'Coats AJS, Anker SD, Lund LH, Filippatos G, Rossignol P, Pitt B, Weir MR, Kosiborod MN, Metra M, Bohm M, Ezekowitz JA, Bayes-Genis A, Mentz RJ, Ponikowski P, Senni M, Cleland JGF, Goudev A, Khintibidze I, Lindenfeld J, Merkely B, Waechter S, Budden J, Perrin A, Butler J. Patiromer for Heart Failure Medication Optimization in Patients With Current or Past Hyperkalemia: DIAMOND Subanalysis. JACC Heart Fail. 2024 Dec;12(12):2026-2037. doi: 10.1016/j.jchf.2024.08.003. Epub 2024 Sep 25.'}, {'pmid': '35900838', 'type': 'DERIVED', 'citation': 'Butler J, Anker SD, Lund LH, Coats AJS, Filippatos G, Siddiqi TJ, Friede T, Fabien V, Kosiborod M, Metra M, Pina IL, Pinto F, Rossignol P, van der Meer P, Bahit C, Belohlavek J, Bohm M, Brugts JJ, Cleland JGF, Ezekowitz J, Bayes-Genis A, Gotsman I, Goudev A, Khintibidze I, Lindenfeld J, Mentz RJ, Merkely B, Montes EC, Mullens W, Nicolau JC, Parkhomenko A, Ponikowski P, Seferovic PM, Senni M, Shlyakhto E, Cohen-Solal A, Szecsody P, Jensen K, Dorigotti F, Weir MR, Pitt B. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. Eur Heart J. 2022 Nov 1;43(41):4362-4373. doi: 10.1093/eurheartj/ehac401.'}, {'pmid': '33608263', 'type': 'DERIVED', 'citation': 'Bolanos JA, Seliger SL. Recurrent Hyperkalemia in Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Treatment: Stuck between a Rock and a Hard Place. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):345-347. doi: 10.2215/CJN.00950121. Epub 2021 Feb 19. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.', 'detailedDescription': "Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and up to 12 weeks Run-in Phase (all subjects will have patiromer initiated and RAASi medications, including mineralocorticoid receptor antagonist (MRA) optimized) and a randomized withdrawal Blinded Treatment Phase.\n\nThe study population includes subjects with heart failure (HF) with reduced ejection fraction (HFrEF) who are hyperkalemic (serum potassium \\[K+\\] \\> 5.0 mEq/L) while receiving treatment with renin angiotensin aldosterone system inhibitor (RAASi) medications or who are normokalemic (serum K+ 4.0 - 5.0 mEq/L) but have a history of hyperkalemia prior to screening with subsequent reduction or discontinuation of a RAASi medication.\n\nEach subject's participation includes a Run-in Phase (maximum 12 weeks) followed by the Treatment Phase (variable per subject). Study duration for individual subjects will vary, depending on their individual enrollment date. Subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of clinical events data and will receive usual care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 18 years or greater\n* Symptomatic low ejection fraction heart failure (weak heart muscle)\n* Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)\n* Kidney function not more than mild or moderately impaired\n* High blood potassium (\\>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications\n* Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.\n\nExclusion Criteria:\n\n* Current acute decompensated HF, within 4 weeks before screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 4 weeks before screening may be included\n* Significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation)\n* Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period'}, 'identificationModule': {'nctId': 'NCT03888066', 'acronym': 'DIAMOND', 'briefTitle': 'Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)', 'orgStudyIdInfo': {'id': 'PAT-CR-302'}, 'secondaryIdInfos': [{'id': '2018-005030-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Patiromer', 'description': 'Subjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.', 'interventionNames': ['Drug: Patiromer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2: Placebo', 'description': 'Subjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Patiromer', 'type': 'DRUG', 'otherNames': ['Veltassa'], 'description': 'The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).', 'armGroupLabels': ['Group 1: Patiromer']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).', 'armGroupLabels': ['Group 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35010', 'city': 'Alexander City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigator Site 11-080', 'geoPoint': {'lat': 32.94401, 'lon': -85.95385}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigator Site 11-041', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85108', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site 11-153', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site 11-097', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93308', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 11-052', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 11-174', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 11-136', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 11-102', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 11-162', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 11-048', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92653', 'city': 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25.81954, 'lon': -80.35533}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-138', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33467', 'city': 'Greenacres City', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-164', 'geoPoint': {'lat': 26.62368, 'lon': -80.12532}}, {'zip': '33033', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-078', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '32224-1865', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-004', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32277', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-179', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33166', 'city': 'Medley', 'state': 'Florida', 'country': 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'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-032', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '32807', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-171', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32810', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-025', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-087', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-177', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33064', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 11-144', 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'facility': 'Investigator Site 11-141', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site 11-031', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60429', 'city': 'Hazel Crest', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site 11-051', 'geoPoint': {'lat': 41.5717, 'lon': -87.69449}}, {'zip': '61602', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site 11-063', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site 11-137', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '46410', 'city': 'Merrillville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigator Site 11-117', 'geoPoint': {'lat': 41.48281, 'lon': -87.33281}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigator Site 11-129', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '47347', 'city': 'Richmond', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigator Site 11-069', 'geoPoint': {'lat': 39.82894, 'lon': -84.89024}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigator Site 11-061', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '70570', 'city': 'Opelousas', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigator Site 11-183', 'geoPoint': {'lat': 30.53353, 'lon': -92.08151}}, {'zip': '71291', 'city': 'West Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigator Site 11-022', 'geoPoint': {'lat': 32.51848, 'lon': -92.14764}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigator Site 11-027', 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'country': 'United States', 'facility': 'Investigator Site 11-189', 'geoPoint': {'lat': 42.68059, 'lon': -83.13382}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Investigator Site 11-068', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigator Site 11-154', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigator Site 11-094', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68256-9797', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigator Site 11-071', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigator Site 11-049', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89086', 'city': 'North Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigator Site 11-145', 'geoPoint': {'lat': 36.19886, 'lon': -115.1175}}, {'zip': '08035', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigator Site 11-088', 'geoPoint': {'lat': 39.87734, 'lon': -75.06462}}, {'zip': '07036', 'city': 'Linden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigator Site 11-054', 'geoPoint': {'lat': 40.62205, 'lon': -74.24459}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigator Site 11-148', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigator Site 11-107', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Investigator Site 11-116', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11203-2012', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 11-151', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11234', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 11-126', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14215-1145', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 11-073', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 11-040', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11419', 'city': 'Richmond Hill', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 11-053', 'geoPoint': {'lat': 40.69983, 'lon': -73.83125}}, {'zip': '10310', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 11-081', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 11-021', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site 11-127', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site 11-120', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site 11-075', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site 11-018', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28358', 'city': 'Lumberton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site 11-157', 'geoPoint': {'lat': 34.61834, 'lon': -79.01045}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site 11-149', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44053', 'city': 'Lorain', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site 11-064', 'geoPoint': {'lat': 41.45282, 'lon': -82.18237}}, {'zip': '43302-6416', 'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site 11-042', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site 11-187', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '74006', 'city': 'Bartlesville', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigator Site 11-074', 'geoPoint': {'lat': 36.74731, 'lon': -95.98082}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigator Site 11-124', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97123', 'city': 'Hillsboro', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigator Site 11-056', 'geoPoint': {'lat': 45.52289, 'lon': -122.98983}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigator Site 11-169', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigator Site 11-165', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigator Site 11-082', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigator Site 11-110', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29646', 'city': 'Greenwood', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigator Site 11-098', 'geoPoint': {'lat': 34.1954, 'lon': -82.16179}}, {'zip': '29720', 'city': 'Lancaster', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigator Site 11-119', 'geoPoint': {'lat': 34.72043, 'lon': -80.7709}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigator Site 11-133', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigator Site 11-152', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigator Site 11-091', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '38117', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigator Site 11-142', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38138', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigator Site 11-083', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37388', 'city': 'Tullahoma', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigator Site 11-134', 'geoPoint': {'lat': 35.36202, 'lon': -86.20943}}, {'zip': '75013', 'city': 'Allen', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11-104', 'geoPoint': {'lat': 33.10317, 'lon': -96.67055}}, {'zip': '75013', 'city': 'Allen', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11-185', 'geoPoint': {'lat': 33.10317, 'lon': -96.67055}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11-070', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11-176', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11-092', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75020', 'city': 'Denison', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11-170', 'geoPoint': {'lat': 33.75566, 'lon': -96.53666}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11-060', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78629', 'city': 'Gonzales', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11-072', 'geoPoint': {'lat': 29.50163, 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'city': 'London', 'country': 'United Kingdom', 'facility': 'Investigator Site 39-015', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE29 8NH', 'city': 'North Shields', 'country': 'United Kingdom', 'facility': 'Investigator Site 39-010', 'geoPoint': {'lat': 55.01646, 'lon': -1.44925}}, {'zip': 'SA6 6NL', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Investigator Site 39-007', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'YO31 8HE', 'city': 'York', 'country': 'United Kingdom', 'facility': 'Investigator Site 39-004', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'Peter Szecsödy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vifor Pharma'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.\n\nData will be indefinitely available 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