Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-04-08 @ 11:10 AM
Study NCT ID:
NCT01885559
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2013-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HALT Progression of Polycystic Kidney Disease Study B
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}, {'id': 'C537180', 'term': 'Familial paroxysmal dystonia'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'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': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'torres.vicente@mayo.edu', 'title': 'Dr. Vicente Torres', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse event data were collected during follow up between 5-8 years with average follow up time of 5.2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.', 'otherNumAtRisk': 242, 'otherNumAffected': 66, 'seriousNumAtRisk': 242, 'seriousNumAffected': 88}, {'id': 'EG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.', 'otherNumAtRisk': 244, 'otherNumAffected': 60, 'seriousNumAtRisk': 244, 'seriousNumAffected': 88}], 'otherEvents': [{'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 51, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 31, 'numAffected': 22}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 65, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 70, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paroxysmal atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Endocrine disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colonic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophageal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophageal varices hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'General disorders and administration site conditions - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sudden death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hepatobiliary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Injury, poisoning and procedural complications - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Injury to carotid artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bladder anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Intraoperative renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Glucose intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ischemia cerebrovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nervous system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pregnancy, puerperium and perinatal conditions - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Renal and urinary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Renal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Reproductive system and breast disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Uterine hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pelvic floor muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Surgical and medical procedures - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vascular disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'OG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.42', 'estimateComment': 'ACE+ARB (Lisinopril-telmisartan) compared to ACE+placebo (Lisinopril-placebo)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analyses were adjusted for age, sex, race, baseline estimated Glomerular Filtration Rate (eGFR) and clinical site'}], 'paramType': 'NUMBER', 'timeFrame': 'Patients followed for 5-8 years with average of 6.5 years follow up', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat analysis was used for the primary outcome'}, {'type': 'SECONDARY', 'title': 'Albuminuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'OG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '9.9'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '9.7'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '2.8', 'statisticalMethod': 'shared parameter model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'shared parameter models used due to informative censoring that occurred when patients did not have secondary outcomes measured after reaching endpoint'}], 'paramType': 'MEAN', 'timeFrame': 'up to 8 years (annually assessed)', 'description': 'Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years.', 'unitOfMeasure': 'annual percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Aldosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'OG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.8', 'groupId': 'OG000', 'lowerLimit': '-10.5', 'upperLimit': '-7.2'}, {'value': '-10.2', 'groupId': 'OG001', 'lowerLimit': '-11.9', 'upperLimit': '-8.6'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '0.7', 'pValueComment': 'controlling for age, sex, race, and clinical site', 'estimateComment': 'ACE-I+ARB annual percent change minus ACE-I + placebo annual percent change', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'up at 8 years (annually assessed)', 'description': 'Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years.', 'unitOfMeasure': 'annual percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analyses'}, {'type': 'SECONDARY', 'title': 'Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'OG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'classes': [{'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.32', 'estimateComment': 'Hazard ratio compares ACE-I + ARB compared to ACE-I + placebo', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'adjusting for age, sex, race, and clinical site and recurrent events'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 8 years', 'description': 'Hospitalization for any cause', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'OG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.6', 'estimateComment': 'Hazard ratio is comparing ACE-I + ARB to ACE-I + placebo', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'adjusting for age, sex, race, and clinical site and accounting for recurrent events'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 8 years', 'description': 'Cause-specific hospitalizations (cardiovascular)', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat analysis'}, {'type': 'SECONDARY', 'title': 'Quality of Life Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'OG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.64', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '-0.50'}, {'value': '-0.68', 'groupId': 'OG001', 'lowerLimit': '-0.84', 'upperLimit': '-0.52'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.032', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.16', 'statisticalMethod': 'shared parameter model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Shared parameter models were used due to informed censoring when patients who reached the primary endpoint were no longer assessed on the measure.'}], 'paramType': 'MEAN', 'timeFrame': 'up to 8 years (annually assessed)', 'description': 'Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.', 'unitOfMeasure': 'units on a scale per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat analysis'}, {'type': 'SECONDARY', 'title': 'Quality of Life Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'OG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.031', 'groupId': 'OG000', 'lowerLimit': '-0.19', 'upperLimit': '0.12'}, {'value': '-0.079', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '0.08'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.047', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.16', 'statisticalMethod': 'shared parameter model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Shared parameter models were used due to the informative censoring when patients who reached endpoint were not longer assessed on this measure.'}], 'paramType': 'MEAN', 'timeFrame': 'up to 8 years (annually assessed)', 'description': 'Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.', 'unitOfMeasure': 'units on a scale per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Back or Flank Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'OG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '50'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '53'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.01', 'estimateComment': 'Odds ratio represents the multiplicative effect of ACE-I + ARB group compared to the ACE-I + placebo group in change in pain over time.\n\nACE-I + ARB OR per month was 1.01 (1.00, 1.01) and ACE-I + placebo OR was 1.01 (1.01, 1.01).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Generalized linear mixed models are used with a logit link. Model controlled for baseline age, sex, race, and clinical site.'}], 'paramType': 'NUMBER', 'timeFrame': '48 months', 'description': 'Report of back or flank pain since the last visit (yes or no)', 'unitOfMeasure': 'percentage of participants at 48 months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross sectional analysis at 48 months is reported only for those participants responding at that time point. Intention to treat analysis was used for in the modeling over time to incorporate all repeated measures.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'FG001', 'title': 'ACE-I + Angiotensin Receptor Blocker (ARB)', 'description': 'ACE-I + angiotensin receptor blocker (ARB) and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'groupId': 'FG001', 'numSubjects': '244'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Less than full participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment for HALT PKD Study B occurred at seven clinical sites between February 2006 and June 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '486', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ACE-I + Placebo', 'description': 'ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'BG001', 'title': 'ACE-I + ARB', 'description': 'ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg\n\nLisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '48.6', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '48.7', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PKD Genotype', 'classes': [{'title': 'PKD1', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}, {'title': 'PKD2', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'No Mutation Detected', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'No data', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age at Diagnosis of Autosomal Dominant Polycystic Kidney Disease (yrs)', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '33.0', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum Creatinine (mg/dl)', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) eGFR (ml/min/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '48.2', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml/min/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-13', 'studyFirstSubmitDate': '2013-06-17', 'resultsFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-02-25', 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.', 'timeFrame': 'Patients followed for 5-8 years with average of 6.5 years follow up'}], 'secondaryOutcomes': [{'measure': 'Albuminuria', 'timeFrame': 'up to 8 years (annually assessed)', 'description': 'Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years.'}, {'measure': 'Aldosterone', 'timeFrame': 'up at 8 years (annually assessed)', 'description': 'Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years.'}, {'measure': 'Hospitalizations', 'timeFrame': 'up to 8 years', 'description': 'Hospitalization for any cause'}, {'measure': 'Cardiovascular Hospitalizations', 'timeFrame': 'up to 8 years', 'description': 'Cause-specific hospitalizations (cardiovascular)'}, {'measure': 'Quality of Life Physical Component Summary', 'timeFrame': 'up to 8 years (annually assessed)', 'description': 'Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.'}, {'measure': 'Quality of Life Mental Component Summary', 'timeFrame': 'up to 8 years (annually assessed)', 'description': 'Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.'}, {'measure': 'Back or Flank Pain', 'timeFrame': '48 months', 'description': 'Report of back or flank pain since the last visit (yes or no)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polycystic kidney disease', 'polycystic', 'kidney', 'disease', 'adpkd', 'halt', 'pkd', 'blood pressure', 'bp', 'hypertension', 'renal', 'renin-angiotensin-aldosterone-system', 'RAAS'], 'conditions': ['Kidney, Polycystic']}, 'referencesModule': {'references': [{'pmid': '39356039', 'type': 'DERIVED', 'citation': 'St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.'}, {'pmid': '37250503', 'type': 'DERIVED', 'citation': 'Chebib FT, Zhou X, Garbinsky D, Davenport E, Nunna S, Oberdhan D, Fernandes A. Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies. Kidney Med. 2023 Apr 14;5(6):100639. doi: 10.1016/j.xkme.2023.100639. eCollection 2023 Jun.'}, {'pmid': '25399731', 'type': 'DERIVED', 'citation': 'Torres VE, Abebe KZ, Chapman AB, Schrier RW, Braun WE, Steinman TI, Winklhofer FT, Brosnahan G, Czarnecki PG, Hogan MC, Miskulin DC, Rahbari-Oskoui FF, Grantham JJ, Harris PC, Flessner MF, Moore CG, Perrone RD; HALT-PKD Trial Investigators. Angiotensin blockade in late autosomal dominant polycystic kidney disease. N Engl J Med. 2014 Dec 11;371(24):2267-76. doi: 10.1056/NEJMoa1402686. Epub 2014 Nov 15.'}], 'seeAlsoLinks': [{'url': 'http://www.pkdcure.org', 'label': 'Polycystic Kidney Disease Foundation Website'}]}, 'descriptionModule': {'briefSummary': 'The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR \\>60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years.\n\nCombination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.', 'detailedDescription': '\\* Specific Aim of Study B\n\nTo study the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in the setting of standard blood pressure control (110-130/80 mm Hg) on the time to a 50% reduction of baseline estimated Glomerular Filtration Rate (eGFR), end-state renal disease (ESRD) or death, in hypertensive individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73m2).\n\n\\* Hypothesis to be tested in Study B\n\nIn hypertensive ADPKD individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73 m2), intensive blockade of the RAAS using combination ACE-I/ARB therapy will slow the decline in kidney function over ACE-I monotherapy, independent of standard blood pressure control (110-130/80 mm Hg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ADPKD.\n* Age 15-49 (Study A); Age 18-64 (Study B).\n* GFR \\>60 mL/min/1.73 m2 (Study A); GFR 25-60 mL/min/1.73 m2 (Study B).\n* BP ≥130/80 or receiving treatment for hypertension.\n* Informed Consent.\n\nExclusion Criteria:\n\n* Pregnant/intention to become pregnant in 4-6 yrs.\n* Documented renal vascular disease.\n* Spot urine albumin-to-creatinine ratio of \\>0.5 (Study A) or ≥1.0 (Study B) and/or findings suggestive of kidney disease other than ADPKD.\n* Diabetes requiring insulin or oral hypoglycemic agents / fasting serum glucose of \\>126 mg/dl / random non-fasting glucose of \\>200 mg/dl.\n* Serum potassium \\>5.5 milliequivalent (mEq) /L for participants currently on ACE-I or ARB; \\>5.0 mEq/L for participants not currently on ACE-I or ARB.\n* History of angioneurotic edema or other absolute contraindication for ACE-I or ARB. Intolerable cough associated with ACE-I is defined as a cough developing within six months of initiation of ACE-I in the absence of other causes and resolving upon discontinuation of the ACE-I.\n* Indication (other than hypertension) for β-blocker or calcium channel blocker therapy (e.g. angina, past myocardial infarction, arrhythmia), unless approved by the site principal investigator. (PI may choose to accept an individual who is on only a small dose of one of these agents and would otherwise be eligible.)\n* Systemic illness necessitating nonsteroidal antiinflammatory drugs (NSAIDs), immunosuppressant or immunomodulatory medications.\n* Systemic illness with renal involvement.\n* Hospitalized for acute illness in past 2 months.\n* Life expectancy \\<2 years.\n* History of non-compliance.\n* Unclipped cerebral aneurysm \\>7mm diameter.\n* Creatine supplements within 3 months of screening visit.\n* Congenital absence of a kidney (also total nephrectomy for Study B).\n* Known allergy to sorbitol or sodium polystyrene sulfonate.\n* Exclusions specific to magnetic resonance (MR) imaging (Study A).'}, 'identificationModule': {'nctId': 'NCT01885559', 'acronym': 'HALT PKD B', 'briefTitle': 'HALT Progression of Polycystic Kidney Disease Study B', 'nctIdAliases': ['NCT00067977'], 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'HALT Progression of Polycystic Kidney Disease Study B', 'orgStudyIdInfo': {'id': 'HALT PKD B'}, 'secondaryIdInfos': [{'id': 'U01DK062401', 'link': 'https://reporter.nih.gov/quickSearch/U01DK062401', 'type': 'NIH'}, {'id': 'U01DK082230', 'link': 'https://reporter.nih.gov/quickSearch/U01DK082230', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'ACE-I + placebo', 'description': 'Monotherapy of lisinopril and placebo. Standard blood pressure control of 110-130/80 mm Hg', 'interventionNames': ['Drug: Lisinopril', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ACE-I + ARB', 'description': 'Dual therapy of lisinopril and telmisartan treatments. Standard blood pressure control of 110-130/80 mm Hg.', 'interventionNames': ['Drug: Lisinopril', 'Drug: Telmisartan']}], 'interventions': [{'name': 'Lisinopril', 'type': 'DRUG', 'otherNames': ['ACE-I', 'ACE', 'Ace-Inhibitor'], 'description': 'Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.', 'armGroupLabels': ['ACE-I + ARB', 'ACE-I + placebo']}, {'name': 'Telmisartan', 'type': 'DRUG', 'otherNames': ['ARB'], 'description': 'Telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.', 'armGroupLabels': ['ACE-I + ARB']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.', 'armGroupLabels': ['ACE-I + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '800045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University-New England Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Robert Schrier, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Arlene Chapman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Ronald Perrone, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University-New England Medical Center'}, {'name': 'Vicente Torres, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Marva Moxey-Mims, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, {'name': 'Charity G Moore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'url': 'https://repository.niddk.nih.gov/studies/halt-pkd/?query=halt%20pkd', 'ipdSharing': 'YES', 'description': 'Data are available at the NIDDK Central Repository, https://repository.niddk.nih.gov/studies/halt-pkd/?query=halt%20pkd'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Polycystic Kidney Disease Foundation', 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}