Viewing Study NCT00416520


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Study NCT ID: NCT00416520
Status: COMPLETED
Last Update Posted: 2014-11-04
First Post: 2006-12-27
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'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': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106574', 'term': 'cholebine'}, {'id': 'D000069603', 'term': 'Sevelamer'}], 'ancestors': [{'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MCI-196 (Open-label Period)', 'description': '3, 6, 9, 12, or 15g/day as titrated', 'otherNumAtRisk': 162, 'otherNumAffected': 126, 'seriousNumAtRisk': 162, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'Sevelamer (Open-label Period)', 'description': '2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated', 'otherNumAtRisk': 169, 'otherNumAffected': 113, 'seriousNumAtRisk': 169, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'MCI-196 (Placebo-Controlled Period)', 'description': 'dose level at the end of dose titration in the flexible dose period', 'otherNumAtRisk': 50, 'otherNumAffected': 20, 'seriousNumAtRisk': 50, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo (Placebo-Controlled Period)', 'description': 'dose level at the end of dose titration in the flexible dose period', 'otherNumAtRisk': 53, 'otherNumAffected': 23, 'seriousNumAtRisk': 53, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Hyperparathyroidism secondary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Catheter site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 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'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Haemodialysis-induced symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Procedural hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Blood parathyroid hormone increased', 'stats': 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG002', 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169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Arteriovenous fistula site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Arteriovenous fistula site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Arteriogram coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Renal transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Toe amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Dialysis device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MCI-196 (Placebo-controlled Withdrawal Period)', 'description': 'dose level at the end of dose titration in the flexible dose period'}, {'id': 'OG001', 'title': 'Placebo (Placebo-controlled Withdrawal Period)', 'description': 'dose level at the end of dose titration in the flexible dose period'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week16 minus week12', 'description': 'ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.', 'unitOfMeasure': 'mg / dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MCI-196 (Open-label Period)', 'description': '3, 6, 9, 12, or 15g/day as titrated'}, {'id': 'OG001', 'title': 'Sevelamer (Open-label Period)', 'description': '2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.12', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-2.16', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week12 minus week0', 'description': 'ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.', 'unitOfMeasure': 'mg / dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MCI-196 (Open-label Period)', 'description': '3, 6, 9, 12, or 15g/day as titrated\n\n* There was a gap of 3 subjects between "STARTED" and "Overall Number of Baseline Participants".\n* Two subjects were randomised to receive MCI-196, but did not take study medication. These 2 subjects were excluded from "Baseline Participants" of MCI-196 group.\n* In addition, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for "STARTED" but counted as Sevelamer group for "Baseline Participants".'}, {'id': 'FG001', 'title': 'Sevelamer (Open-label Period)', 'description': '2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated\n\n* There was a gap of 2 subjects between "STARTED" and "Overall Number of Baseline Participants".\n* Three subjects in Sevelamer group were randomised in error and did not take any study medication. These 3 subjects were excluded from "Baseline Participants" of Sevelamer group.\n* However, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for "STARTED" but counted as Sevelamer group for "Baseline Participants".'}, {'id': 'FG002', 'title': 'MCI-196 (Placebo-controlled Withdrawal Period)', 'description': 'dose level at the end of dose titration in the flexible dose period'}, {'id': 'FG003', 'title': 'Placebo (Placebo-controlled Withdrawal Period)', 'description': 'dose level at the end of dose titration in the flexible dose period\n\nThere was a gap of 1 subject between "STARTED" and "Overall Number of Baseline Participants" One subject did not take any study medication and excluded from "Baseline Participants".'}], 'periods': [{'title': 'Open-label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '171'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Placebo-controlled Withdrawal Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MCI-196 (Open-label Period)'}, {'id': 'BG001', 'title': 'Sevelamer (Open-label Period)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-28', 'studyFirstSubmitDate': '2006-12-27', 'resultsFirstSubmitDate': '2014-08-22', 'studyFirstSubmitQcDate': '2006-12-27', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-20', 'studyFirstPostDateStruct': {'date': '2006-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)', 'timeFrame': 'week16 minus week12', 'description': 'ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)', 'timeFrame': 'week12 minus week0', 'description': 'ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Dialysis', 'Hyperphosphatemia', 'Phosphate binder'], 'conditions': ['Chronic Kidney Disease', 'Hyperphosphatemia']}, 'referencesModule': {'references': [{'pmid': '40576086', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or over\n* Clinically stable haemodialysis or peritoneal dialysis\n* Stable phosphate control\n* On a stabilised phosphorus diet\n* Female and of child-bearing potential have a negative serum pregnancy test.\n* Male subjects must agree to use appropriate contraception.\n\nExclusion Criteria:\n\n* Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.\n* Body Mass Index (BMI) \\<=16.0 kg/m2 or \\>=40.0 kg/m2\n* A current or history of significant gastrointestinal motility problems\n* A positive test for HIV 1 and 2 antibodies\n* A history of substance or alcohol abuse within the last year.\n* Seizure disorders\n* A history of drug or other allergy\n* A temporary catheter as a vascular access\n* Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent'}, 'identificationModule': {'nctId': 'NCT00416520', 'briefTitle': 'A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia', 'orgStudyIdInfo': {'id': 'MCI-196-E07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Another phosphate binder (Sevelamer)']}], 'interventions': [{'name': 'MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)', 'type': 'DRUG', 'description': '3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind', 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