Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-30 @ 6:44 PM
Study NCT ID:
NCT01324128
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2011-03-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007501', 'term': 'Iron'}, {'id': 'D000069603', 'term': 'Sevelamer'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@viforpharma.com', 'phone': '41 58 851 8222', 'title': 'Medical Information', 'organization': 'Vifor Pharma'}, 'certainAgreement': {'otherDetails': 'Investigators may not present or publish partial or complete study results individually. Any manuscript or abstract proposed by the Investigators must be reviewed and approved in writing by Vifor Pharma before submission for publication. Names of all Investigators participating in the study will be included in the publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'PA21 Stage 1', 'description': 'PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).', 'otherNumAtRisk': 707, 'otherNumAffected': 426, 'seriousNumAtRisk': 707, 'seriousNumAffected': 129}, {'id': 'EG001', 'title': 'Sevelamer Carbonate Stage 1', 'description': 'Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).', 'otherNumAtRisk': 348, 'otherNumAffected': 162, 'seriousNumAtRisk': 348, 'seriousNumAffected': 69}, {'id': 'EG002', 'title': 'PA21-1 (LD) Stage 2', 'description': 'PA21-1 (1.25 g tablet). Low Dose (LD) comparator (1.25 g/day) for Stage 2.', 'otherNumAtRisk': 49, 'otherNumAffected': 10, 'seriousNumAtRisk': 49, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'PA21 (MD) Stage 2', 'description': 'PA21 (2.5g tablet) Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.', 'otherNumAtRisk': 45, 'otherNumAffected': 2, 'seriousNumAtRisk': 45, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 184, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13.1)'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 110, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13.1)'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 114, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 39, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 60, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 41, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 54, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 39, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra (13.1)'}], 'seriousEvents': [{'term': 'Abdominal hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous fistula aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous fistula operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous fistula site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous fistula site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous fistula site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous graft site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous graft site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 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'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Umbilical hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vascular graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Toxic encelphalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mental impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 707, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Phosphorus Levels From Week 24 to Week 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21 (MD) Stage 2', 'description': 'PA21 Stage 2 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.'}, {'id': 'OG001', 'title': 'PA21-1 (LD) Stage 2', 'description': 'PA21-1 Low Dose (LD) comparator (1.25 g/day) for Stage 2'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24, Week 27', 'description': 'Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Primary Outcome, data from the Primary Efficacy Set (PES) was used. The PES consists of subjects who were randomized to Stage 2 and received at least 1 dose of study medication during Stage 2 and had at least 1 post-baseline (Stage 2) efficacy assessment in Stage 2.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Phosphorus Levels From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '461', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21 (2.5 g Tablet) Stage 1', 'description': 'PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).'}, {'id': 'OG001', 'title': 'Sevelamer Carbonate Stage 1', 'description': 'Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.19', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-2.45', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12 post Baseline', 'description': 'Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Secondary Outcome, data from the Per Protocol Set (PPS) was used. The PPS consists of all subjects who had completed the analysis dose titration period (baseline to Week 12), had at least 1 evaluable serum phosphorus result at or after Week 12, and had no major protocol deviations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PA21 Stage 1', 'description': 'PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).'}, {'id': 'FG001', 'title': 'Sevelamer Carbonate Stage 1', 'description': 'Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).'}, {'id': 'FG002', 'title': 'PA21 (MD) Stage 2', 'description': 'PA21 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1'}, {'id': 'FG003', 'title': 'PA21-1 (LD) Stage 2', 'description': 'PA21-1 (1.25 g/day) Low Dose (LD) comparator for Stage 2.'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '710'}, {'groupId': 'FG001', 'numSubjects': '349'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '515'}, {'groupId': 'FG001', 'numSubjects': '293'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The first 100HD subjects that completed Stage 1 in the PA21 treatment group entered Stage 2 and were randomised to PA21 Maintenance Dose (MD) or PA21-1 Low Dose (LD). Due to a randomisation error only 99 subjects were randomised into Stage 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '710', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '1059', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PA21 Stage 1', 'description': 'PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).'}, {'id': 'BG001', 'title': 'Sevelamer Carbonate Stage 1', 'description': 'Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '512', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '754', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '13.35', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '14.59', 'groupId': 'BG001'}, {'value': '56.2', 'spread': '13.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '396', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '616', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '516', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'For baseline characteristics, data from All Randomised patients was used.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1059}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'dispFirstSubmitDate': '2012-12-07', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-03', 'studyFirstSubmitDate': '2011-03-24', 'dispFirstSubmitQcDate': '2012-12-10', 'resultsFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2011-03-25', 'dispFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-03', 'studyFirstPostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Phosphorus Levels From Week 24 to Week 27', 'timeFrame': 'Week 24, Week 27', 'description': 'Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27'}], 'secondaryOutcomes': [{'measure': 'Change in Serum Phosphorus Levels From Baseline to Week 12', 'timeFrame': 'Week 12 post Baseline', 'description': 'Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PA21', 'Phosphate Binder'], 'conditions': ['Chronic Kidney Disease Requiring Chronic Dialysis']}, '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.'}, {'pmid': '29656600', 'type': 'DERIVED', 'citation': 'Sprague SM, Ketteler M, Covic AC, Floege J, Rakov V, Walpen S, Rastogi A. Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients. Hemodial Int. 2018 Oct;22(4):480-491. doi: 10.1111/hdi.12663. Epub 2018 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)\n* Stable dose of phosphate binder\n* Written informed consent\n\nExclusion Criteria:\n\n* Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)\n* Other significant medical conditions\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01324128', 'briefTitle': 'A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia', 'orgStudyIdInfo': {'id': 'PA-CL-05A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PA21 (2.5 g tablet)', 'interventionNames': ['Drug: PA21 (2.5 g tablet containing 500 mg iron)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sevelamer carbonate', 'interventionNames': ['Drug: Sevelamer carbonate']}, {'type': 'OTHER', 'label': 'PA21-1 (1.25 g tablet)', 'interventionNames': ['Drug: PA21-1 (1.25 g tablet containing 250 mg iron)']}], 'interventions': [{'name': 'PA21 (2.5 g tablet containing 500 mg iron)', 'type': 'DRUG', 'description': 'Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).', 'armGroupLabels': ['PA21 (2.5 g tablet)']}, {'name': 'Sevelamer carbonate', 'type': 'DRUG', 'description': 'Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)', 'armGroupLabels': ['Sevelamer carbonate']}, {'name': 'PA21-1 (1.25 g tablet containing 250 mg iron)', 'type': 'DRUG', 'description': 'Low dose comparator (1.25 g/day)', 'armGroupLabels': ['PA21-1 (1.25 g tablet)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '3100', 'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'LKH St. Polten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Clinical Hospital Center Rijeka', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '35601', 'city': 'Sokolov', 'country': 'Czechia', 'facility': 'Dialysis Centre Fresenius Medical Care', 'geoPoint': {'lat': 50.1813, 'lon': 12.6401}}, {'zip': '12045', 'city': 'Berlin', 'country': 'Germany', 'facility': 'KfH Nierenzentrum Berlin-Neukoelln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'LV-4201', 'city': 'Valmiera', 'country': 'Latvia', 'facility': 'Vidzemes Hospital', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'zip': 'LT-08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital Santariskiu Clinics', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Teaching Hospital no.1 of Medical University of Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '550135', 'city': 'Sibiu', 'country': 'Romania', 'facility': 'Dialmed Clinic SRL', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'zip': '191104', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Mariinsky Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Zvezdara Clinical Medical Center', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '1500', 'city': 'Benoni', 'country': 'South Africa', 'facility': 'Lakeview Hospital', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'zip': '54058', 'city': 'Mykolayiv', 'country': 'Ukraine', 'facility': 'Mykolayiv Regional Hospital', 'geoPoint': {'lat': 46.97625, 'lon': 31.99296}}, {'zip': 'DT1 2JY', 'city': 'Dorset', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital NHS Foundation Trust'}], 'overallOfficials': [{'name': 'Juergen Floege, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Klinik II'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vifor Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}