A Phase 3 Extension Study to Investigate the Long-term Sa... | NCT01464190

Name	Class
Fresenius Medical Care North America	INDUSTRY

Label	Type	Description	Intervention Names
PA21	Experimental		Drug: PA21 (2.5 g tablet containing 500 mg iron)
Sevelamer carbonate	Active Comparator		Drug: Sevelamer carbonate

Name	Type	Description	Arm Group Labels	Other Names
PA21 (2.5 g tablet containing 500 mg iron)	Drug	Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).	PA21

Measure	Description	Time Frame
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.	Every 4 weeks from baseline to Week 28
Change From Baseline and Levels at Each Time Point for Serum Calcium	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.	Every 4 weeks from baseline to Week 28
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.	Every 4 weeks from baseline to Week 28

Name	Affiliation	Role
Juergen Floege, MD	Medizinische Klinik II	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
		San Antonio	Texas	78215	United States
Medizinische Abteilung Nephrologie und Dialyse

PubMed Identifier	Type	Citation	Retractions
40576086	Derived	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.
29656600	Derived	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.

ID	Title	Description
FG000	PA21	PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day)
FG001	Sevelamer Carbonate	Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

ID	Title	Description
BG000	PA21	PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
BG001	Sevelamer Carbonate	Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000391 BG001268 BG002659

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal operation	Surgical and medical procedures	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Abscess limb	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events3 affected267 at risk
Aneurysm ruptured	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Angina pectoris	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected267 at risk
Angina unstable	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Aortic aneurysm	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Aortic stenosis	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Appendicitis perforated	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Arterial stenosis	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Arterial thrombosis	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Arteriosclerosis	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected267 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0012 events2 affected267 at risk
Arteriovenous graft	Surgical and medical procedures	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events3 affected267 at risk
Bacteraemia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Bradycardia	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Cardiac arrest	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Cardiac failure	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0004 events3 affected391 at risk EG0011 events1 affected267 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Catheter site infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Cellulitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected267 at risk
Cerebral infarction	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected267 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Chest pain	General disorders	MedDRA (13.1)	Systematic Assessment	EG0004 events3 affected391 at risk EG0011 events1 affected267 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected267 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (13.1)	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected267 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Circulatory collapse	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Convulsion	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Coronary artery disease	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events1 affected267 at risk
Device occlusion	General disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Diabetic foot	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Diverticulitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Erysipelas	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Eye haemorrhage	Eye disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0005 events4 affected391 at risk EG0016 events6 affected267 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Gangrene	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected267 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Gastroenteritis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected267 at risk
Graft infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Groin abscess	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Haematoma	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0004 events4 affected391 at risk EG0010 events0 affected267 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Haemorrhage	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected267 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Hypertensive crisis	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Hypocoagulable state	Blood and lymphatic system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Hypotension	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected267 at risk
Intermittent claudication	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
International normalised ratio increased	Investigations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Ischaemia	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Joint abscess	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Left ventricular failure	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Lobar pneumonia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected267 at risk
Localised infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0012 events2 affected267 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Medical device complication	General disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (13.1)	Systematic Assessment	EG0002 events1 affected391 at risk EG0010 events0 affected267 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Myocardial infarction	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Non-cardiac chest pain	General disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Orchitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Osteomyelitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected267 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0003 events3 affected391 at risk EG0011 events1 affected267 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Peritonsillar abscess	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Pneumonia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0006 events6 affected391 at risk EG0016 events6 affected267 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected267 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0014 events3 affected267 at risk
Pyrexia	General disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Renal cell carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Renal cyst ruptured	Renal and urinary disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Renal failure	Renal and urinary disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Renal mass	Renal and urinary disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Sepsis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0003 events3 affected391 at risk EG0011 events1 affected267 at risk
Septic shock	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected267 at risk
Shunt malfunction	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events1 affected267 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected267 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Syncope	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Thrombophlebitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Thrombosis	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Thrombosis in device	General disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Troponin increased	Investigations	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected267 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected267 at risk
Urinary tract infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected267 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected267 at risk
Wound infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected267 at risk

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements
D008670	Metals
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PA21	PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).			78	391	208	391
EG001	Sevelamer Carbonate	Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).			52	267	169	267