Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-19 @ 5:51 AM
Study NCT ID:
NCT01219959
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2010-10-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077607', 'term': 'Icodextrin'}, {'id': 'C482915', 'term': 'Nutrineal'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Global.CORP.ClinicalTrialsDisclosure@vantive.com', 'phone': '+1 2249484283', 'title': 'Global CORP Clinical Trials Disclosure', 'organization': 'Vantive'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This is a pooled analysis of NCT00567489, NCT00567398, and NCT01219959. Given that the glucose content of the PD solutions were similar, the pooling of the results were considered a valid method to answer the underlying research questions.'}}, 'adverseEventsModule': {'description': 'The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.', 'eventGroups': [{'id': 'EG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only', 'otherNumAtRisk': 127, 'otherNumAffected': 101, 'seriousNumAtRisk': 127, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.', 'otherNumAtRisk': 124, 'otherNumAffected': 98, 'seriousNumAtRisk': 124, 'seriousNumAffected': 58}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiorespiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ischemic Heart Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Left Atrial Enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerumen Impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Deafness Neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperparathyroidism Secondary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diabetic Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eye Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myodesopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vitreous Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bloody Peritoneal Effluent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diabetic Gastropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epigastric Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Impaired Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mallory-Weiss Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nauseas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain In Teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peptic Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peritoneal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peritonitis Associated To Peritoneal Dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peritonitis By Cap', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peritonitis By Capd', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Reflux Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Application 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Post Traumatic Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Right Basal Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thigh Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vestibular Neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood Glucose Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Calciphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diabetic Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fluid Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Severe Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gouty Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Soft Tissue Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cervix Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cognitive Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertensive Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sensory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thalamic Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Decubitus Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diabetic Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Left Malleolus Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Local Infection Of The Skin (Diabetic Sore)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood Pressure Inadequately Controlled', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertensive Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From the Baseline Value in HbA1c at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.2', 'ciUpperLimit': '0.9', 'groupDescription': 'Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489, NCT00567398, NCT01219959.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Insulin: Month 3', 'categories': [{'measurements': [{'value': '3.5', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Insulin: Month 6', 'categories': [{'measurements': [{'value': '2.9', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '23.9', 'groupId': 'OG001'}]}]}, {'title': 'Oral hypoglycemic: Month 3', 'categories': [{'measurements': [{'value': '1.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '5', 'spread': '51.3', 'groupId': 'OG001'}]}]}, {'title': 'Oral hypoglycemic: Month 6', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '52.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.312', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '14.7', 'groupDescription': 'Insulin-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.342', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '14.4', 'groupDescription': 'Insulin-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis used data from prescription information of concomitant medications reported. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Number of Severe Hypoglycemic Event Requiring Medical Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 6 (End of Study)', 'description': "Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as \\< 50mg/dL (\\<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.", 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Cholesterol: Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'LDLC: Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'LDLC: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'HDLC: Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'HDLC: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'VLDL: Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'VLDL: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides: Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.9', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0', 'ciUpperLimit': '0.7', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.593', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.4', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.298', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.2', 'ciUpperLimit': '0.6', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.4', 'ciUpperLimit': '1.3', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Lp(a): Month 3 (n=118,120)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Lp(a): Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '18', 'groupId': 'OG001'}]}]}, {'title': 'Apo A1: Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'Apo A1: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Apo B: Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Apo B: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '23.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.485', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '4.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '4.4', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '12.2', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.134', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '11.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '3.6', 'ciUpperLimit': '19.2', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '0.8', 'ciUpperLimit': '15.9', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Insulin: Month 3', 'categories': [{'measurements': [{'value': '70.3', 'spread': '514.2', 'groupId': 'OG000'}, {'value': '69.4', 'spread': '809.4', 'groupId': 'OG001'}]}]}, {'title': 'Insulin: Month 6', 'categories': [{'measurements': [{'value': '146.3', 'spread': '616', 'groupId': 'OG000'}, {'value': '96.6', 'spread': '1301.9', 'groupId': 'OG001'}]}]}, {'title': 'C-peptide: Month 3', 'categories': [{'measurements': [{'value': '340.8', 'spread': '2393.7', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '2687.2', 'groupId': 'OG001'}]}]}, {'title': 'C-peptide: Month 6', 'categories': [{'measurements': [{'value': '388.3', 'spread': '2660.5', 'groupId': 'OG000'}, {'value': '504.1', 'spread': '2462.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.655', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.5', 'ciLowerLimit': '-304.6', 'ciUpperLimit': '191.7', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.811', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.2', 'ciLowerLimit': '-268.9', 'ciUpperLimit': '210.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.419', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '441.3', 'ciLowerLimit': '-630.4', 'ciUpperLimit': '1513.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.820', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '121.8', 'ciLowerLimit': '-927.9', 'ciUpperLimit': '1171.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Pro-Insulin: Month 3', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '13', 'spread': '71.3', 'groupId': 'OG001'}]}]}, {'title': 'Pro-Insulin: Month 6', 'categories': [{'measurements': [{'value': '3', 'spread': '41.9', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '33.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.721', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-27.5', 'ciUpperLimit': '19', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.247', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.5', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '36.4', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': '+2 Score', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '+1 Score', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': '0 Score', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': '-1 Score', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': '-2 Score', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '-3 Score', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.624', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.43', 'groupDescription': 'Estimates of Ratio-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Month 6 (End of Study)', 'description': 'Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Albumin: Month 3', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Albumin: Month 6', 'categories': [{'measurements': [{'value': '0.5', 'spread': '3', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein: Month 3', 'categories': [{'measurements': [{'value': '0.1', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein: Month 6', 'categories': [{'measurements': [{'value': '0.7', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.338', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.8', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.1', 'ciUpperLimit': '2.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.817', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '1.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '2.9', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'PNA: Month 3', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'PNA: Month 6', 'categories': [{'measurements': [{'value': '1', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'nPNA: Month 3', 'categories': [{'measurements': [{'value': '0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'nPNA: Month 6', 'categories': [{'measurements': [{'value': '0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.127', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.2', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '2.9', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.3', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '-4.3', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '-0.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '-0.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. 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The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.4', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '0.5', 'ciUpperLimit': '5.8', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3', 'ciLowerLimit': '0.5', 'ciUpperLimit': '5.6', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.2', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '3.4', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-3', 'ciUpperLimit': '4.3', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.961', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '1.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.871', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '3.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Protein: Month 3', 'categories': [{'measurements': [{'value': '-5.6', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '45.3', 'groupId': 'OG001'}]}]}, {'title': 'Protein: Month 6', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '32.9', 'groupId': 'OG001'}]}]}, {'title': 'Calories: Month 3', 'categories': [{'measurements': [{'value': '-76.8', 'spread': '316.9', 'groupId': 'OG000'}, {'value': '-199.1', 'spread': '525.1', 'groupId': 'OG001'}]}]}, {'title': 'Calories: Month 6', 'categories': [{'measurements': [{'value': '30.9', 'spread': '589.5', 'groupId': 'OG000'}, {'value': '108', 'spread': '654', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.608', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '25', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.731', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-11.5', 'ciUpperLimit': '8.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.377', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '185.3', 'ciLowerLimit': '-227.5', 'ciUpperLimit': '598.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.854', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.3', 'ciLowerLimit': '-214.4', 'ciUpperLimit': '177.8', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.412', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.07', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.485', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.03', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Month 3', 'categories': [{'measurements': [{'value': '-2.33', 'spread': '23.37', 'groupId': 'OG000'}, {'value': '-2.58', 'spread': '27.14', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '24.02', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '30.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.525', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '-4.56', 'ciUpperLimit': '8.93', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.995', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-6.79', 'ciUpperLimit': '6.83', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Psychology, fatigue: Month 3', 'categories': [{'measurements': [{'value': '2.34', 'spread': '20.73', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '20.33', 'groupId': 'OG001'}]}]}, {'title': 'Psychology, fatigue: Month 6', 'categories': [{'measurements': [{'value': '2.48', 'spread': '22.95', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '24.64', 'groupId': 'OG001'}]}]}, {'title': 'Psychology, cognitive: Month 3', 'categories': [{'measurements': [{'value': '0.16', 'spread': '18.54', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '18.38', 'groupId': 'OG001'}]}]}, {'title': 'Psychology, cognitive: Month 6', 'categories': [{'measurements': [{'value': '2.23', 'spread': '18.87', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '17.23', 'groupId': 'OG001'}]}]}, {'title': 'Neurology, pain: Month 3', 'categories': [{'measurements': [{'value': '-3.46', 'spread': '17.87', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '19.18', 'groupId': 'OG001'}]}]}, {'title': 'Neurology, pain: Month 6', 'categories': [{'measurements': [{'value': '-1.57', 'spread': '21.09', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '22.34', 'groupId': 'OG001'}]}]}, {'title': 'Neurology, sensory: Month 3', 'categories': [{'measurements': [{'value': '-2.25', 'spread': '16.96', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '16.09', 'groupId': 'OG001'}]}]}, {'title': 'Neurology, sensory: Month 6', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '17.15', 'groupId': 'OG000'}, {'value': '-3.59', 'spread': '15.76', 'groupId': 'OG001'}]}]}, {'title': 'Cardiology: Month 3', 'categories': [{'measurements': [{'value': '1.18', 'spread': '17.32', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '15.84', 'groupId': 'OG001'}]}]}, {'title': 'Cardiology: Month 6', 'categories': [{'measurements': [{'value': '3.60', 'spread': '17.74', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '18.11', 'groupId': 'OG001'}]}]}, {'title': 'Ophthalmology: Month 3', 'categories': [{'measurements': [{'value': '1.53', 'spread': '21.98', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '19.71', 'groupId': 'OG001'}]}]}, {'title': 'Ophthalmology: Month 6', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '24.53', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '19.43', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Month 3', 'categories': [{'measurements': [{'value': '0.49', 'spread': '20.72', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '21.02', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia: Month 6', 'categories': [{'measurements': [{'value': '0.50', 'spread': '22.25', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '21.72', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Month 3', 'categories': [{'measurements': [{'value': '-2.07', 'spread': '17.38', 'groupId': 'OG000'}, {'value': '-1.79', 'spread': '18.83', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia: Month 6', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '19.50', 'groupId': 'OG000'}, {'value': '-2.82', 'spread': '18.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.87', 'ciLowerLimit': '-7.64', 'ciUpperLimit': '3.91', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.779', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '-5.01', 'ciUpperLimit': '6.68', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.246', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.95', 'ciLowerLimit': '-7.95', 'ciUpperLimit': '2.04', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.780', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-5.78', 'ciUpperLimit': '4.34', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.885', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '-5.22', 'ciUpperLimit': '6.04', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.41', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '10.10', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '-4.40', 'ciUpperLimit': '6.54', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.21', 'ciLowerLimit': '1.70', 'ciUpperLimit': '12.73', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.934', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-4.63', 'ciUpperLimit': '5.03', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.209', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.13', 'ciLowerLimit': '-1.75', 'ciUpperLimit': '8.01', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.585', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.89', 'ciLowerLimit': '-4.90', 'ciUpperLimit': '8.68', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.641', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '-5.22', 'ciUpperLimit': '8.47', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.586', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.50', 'ciLowerLimit': '-6.89', 'ciUpperLimit': '3.90', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.906', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-5.79', 'ciUpperLimit': '5.14', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.970', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-4.93', 'ciUpperLimit': '4.75', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.38', 'ciLowerLimit': '-2.52', 'ciUpperLimit': '7.28', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of MRI Body Composition at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'Abdominal Visceral Fat Volume: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-49', 'spread': '81.7', 'groupId': 'OG000'}, {'value': '-64.8', 'spread': '73.2', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Subcutaneous Fat Volume: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12', 'spread': '58.9', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '70.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.495', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.6', 'ciLowerLimit': '-46.9', 'ciUpperLimit': '96', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '55.4', 'ciLowerLimit': '-7', 'ciUpperLimit': '117.8', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used in this analysis. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'LV End Diastolic Volume', 'categories': [{'measurements': [{'value': '2.1', 'spread': '35.5', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '28.4', 'groupId': 'OG001'}]}]}, {'title': 'LV End Systolic Volume', 'categories': [{'measurements': [{'value': '3.3', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '28.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.3', 'ciLowerLimit': '-19.3', 'ciUpperLimit': '31.9', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.486', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '30.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT of MRI sub-study (n=88 consented to participate),however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'title': 'LV Mass Without Pap Muscles', 'categories': [{'measurements': [{'value': '0.6', 'spread': '38.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '26.5', 'groupId': 'OG001'}]}]}, {'title': 'LV Mass With Pap Muscles', 'categories': [{'measurements': [{'value': '1.1', 'spread': '39.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '26.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.832', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-18.9', 'ciUpperLimit': '23.4', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.820', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-18.3', 'ciUpperLimit': '23.1', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'OG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '10.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.955', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '6.5', 'groupDescription': 'Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'FG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Renal Transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-Glucose Sparing Prescriptions', 'description': 'Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only'}, {'id': 'BG001', 'title': 'Glucose Sparing Prescriptions', 'description': 'Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '12', 'groupId': 'BG001'}, {'value': '57.65', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Asian', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2010-10-08', 'resultsFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-20', 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From the Baseline Value in HbA1c at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Number of Severe Hypoglycemic Event Requiring Medical Intervention', 'timeFrame': 'Baseline through Month 6 (End of Study)', 'description': "Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as \\< 50mg/dL (\\<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed."}, {'measure': 'Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6', 'timeFrame': 'Baseline and Month 6 (End of Study)', 'description': 'Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished.'}, {'measure': 'Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6', 'timeFrame': 'Baseline, Month 3, Month 6 (End of Study)', 'description': 'The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of MRI Body Composition at Month 6', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}, {'measure': 'Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6', 'timeFrame': 'Baseline, Month 6 (End of Study)', 'description': 'Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ESRD', 'Diabetes', 'CAPD'], 'conditions': ['End Stage Renal Disease (ESRD)', 'Diabetes', 'CAPD']}, 'descriptionModule': {'briefSummary': 'Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.\n\nSecondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female patients 18 years of age or older\n2. Diagnosis of ESRD \\[Glomerular Filtration Rate (GFR) ≤ 15 mL/min\\]\n3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time\n4. Diabetes Mellitus (Type 1 and 2)\n5. HbA1c \\> 6.0% but ≤ 12.0%\n6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL\n7. Total Kt/V ≥ 1.7\n\nExclusion Criteria:\n\n1. Blood Urea Nitrogen (BUN) \\> 95 mg/dL\n2. Exposure to Extraneal within 60 days of Screening\n3. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \\< 77mm Hg) at Screening\n4. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days\n5. Cardiovascular event within the last 30 days\n6. Ongoing clinically significant congestive heart failure \\[New York Heart Association (NYHA) class III or IV\\]\n7. Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance\n8. Receiving rosiglitazone maleate'}, 'identificationModule': {'nctId': 'NCT01219959', 'acronym': 'EDEN', 'briefTitle': 'Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vantive Health LLC'}, 'officialTitle': 'Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in the Treatment of Diabetic CAPD Patients', 'orgStudyIdInfo': {'id': '51067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-glucose Sparing', 'description': 'Dianeal only', 'interventionNames': ['Drug: Dianeal']}, {'type': 'EXPERIMENTAL', 'label': 'Glucose Sparing', 'description': 'Dianeal, Extraneal, Nutrineal', 'interventionNames': ['Drug: Dianeal, Extraneal, Nutrineal']}], 'interventions': [{'name': 'Dianeal', 'type': 'DRUG', 'description': 'Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose', 'armGroupLabels': ['Non-glucose Sparing']}, {'name': 'Dianeal, Extraneal, Nutrineal', 'type': 'DRUG', 'description': 'Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin', 'armGroupLabels': ['Glucose Sparing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Armenia', 'country': 'Colombia', 'facility': 'Nefrosalud Ltda', 'geoPoint': {'lat': 4.53656, 'lon': -75.67263}}, {'city': 'Barranquilla', 'country': 'Colombia', 'facility': 'RTS Ltda Barranquila', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'RTS Ltda Soledad', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bucaramanga', 'country': 'Colombia', 'facility': 'Rts Ltda Ag H.U.S', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'RTS Ltda H.U.V', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'RTS Ltda STR del Valle', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'RTS Ltda Versalles', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Cartagena', 'country': 'Colombia', 'facility': 'Renal Therapy Services (RTS) Ltda Cartagena', 'geoPoint': {'lat': 10.39817, 'lon': -75.49328}}, {'city': 'Cúcuta', 'country': 'Colombia', 'facility': 'RTS Ltda Cucuta', 'geoPoint': {'lat': 7.90745, 'lon': -72.5049}}, {'city': 'Girardot', 'country': 'Colombia', 'facility': 'RTS Ltda Girardot', 'geoPoint': {'lat': 7.12287, 'lon': -73.13534}}, {'city': 'Ibagué', 'country': 'Colombia', 'facility': 'Unidad Renal de Tolima', 'geoPoint': {'lat': 4.43573, 'lon': -75.20289}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'RTS Ltda Sucursal Medellin', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'RTS Ltda Valle de Aburra', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Sogamoso', 'country': 'Colombia', 'facility': 'RTS Ltda Sogamoso', 'geoPoint': {'lat': 5.71434, 'lon': -72.93391}}, {'city': 'Tuluá', 'country': 'Colombia', 'facility': 'RTS Sucrusal Tulua', 'geoPoint': {'lat': 4.08466, 'lon': -76.19536}}, {'city': 'Villavicencio', 'country': 'Colombia', 'facility': 'RTS Ltda Villavicencio', 'geoPoint': {'lat': 4.13238, 'lon': -73.62564}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vantive Health LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}