A Phase 3 Study to Investigate the Safety and Efficacy of... | NCT01324128

NCT01324128

Status Module

Name	Class
Fresenius Medical Care North America	INDUSTRY

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
PA21 (2.5 g tablet)	Experimental	Drug: PA21 (2.5 g tablet containing 500 mg iron)
Sevelamer carbonate	Active Comparator	Drug: Sevelamer carbonate
PA21-1 (1.25 g tablet)	Other	Drug: PA21-1 (1.25 g tablet containing 250 mg iron)

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 (2.5 g tablet)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Serum Phosphorus Levels From Week 24 to Week 27	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	Week 24, Week 27

Secondary Outcomes

Measure	Description	Time Frame
Change in Serum Phosphorus Levels From Baseline to Week 12	Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.	Week 12 post Baseline

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
		San Antonio	Texas	78215	United States
LKH St. Polten

References Module

Citations

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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	PA21 Stage 1	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 Stage 1	Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	PA21 Stage 1	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 Stage 1	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	BG000710 BG001349 BG0021059

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.3± 13.35 BG00155.8± 14.59 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000314 BG001129 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000345 BG001171 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Serum Phosphorus Levels From Week 24 to Week 27

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

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.

Posted

Least Squares Mean

Standard Deviation

mg/dL

Week 24, Week 27

ID	Title	Description
OG000	PA21 (MD) Stage 2	PA21 Stage 2 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
OG001	PA21-1 (LD) Stage 2	PA21-1 Low Dose (LD) comparator (1.25 g/day) for Stage 2

Units	Counts
Participants	OG00044 OG00149

Title

Denominators

Categories

Title	Measurements
	OG0000.25± 0.23 OG0011.92± 0.23

Secondary

Change in Serum Phosphorus Levels From Baseline to Week 12

Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.

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.

Posted

Least Squares Mean

Standard Error

mg/dL

Week 12 post Baseline

ID	Title	Description
OG000	PA21 (2.5 g Tablet) Stage 1	PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
OG001	Sevelamer Carbonate Stage 1	Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PA21 Stage 1	PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).	129	707	426	707
EG001	Sevelamer Carbonate Stage 1	Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).	69	348	162	348
EG002	PA21-1 (LD) Stage 2	PA21-1 (1.25 g tablet). Low Dose (LD) comparator (1.25 g/day) for Stage 2.	6	49	10	49
EG003	PA21 (MD) Stage 2	PA21 (2.5g tablet) Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.	2	45	2	45

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG0030 events0 affected45 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Abscess limb	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0009 events9 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Acute tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0013 events3 affected348 at risk EG0020 events0 affected49 at risk EG003
Aneurysm	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Angioplasty	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Appendicitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Arterial thrombosis limb	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0012 events2 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous fistula site infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected707 at risk EG0012 events2 affected348 at risk EG0021 events1 affected49 at risk EG003
Arteriovenous graft	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous graft site infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Ateriovenous shunt operation	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0012 events2 affected348 at risk EG0020 events0 affected49 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Bactiuria	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Bleeding varicose vein	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Blood glucose abnormal	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Calciphylaxis	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Catheterisation cardiac	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0009 events8 affected707 at risk EG0016 events5 affected348 at risk EG0020 events0 affected49 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Clostridial infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Congestive cardiac failure	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0006 events6 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Death	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Dementia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Device related infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0012 events2 affected348 at risk EG0021 events1 affected49 at risk EG003
Diabetic eye disease	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0021 events1 affected49 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Dizziness	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Duodenitis haemorrhagic	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected707 at risk EG0014 events4 affected348 at risk EG0020 events0 affected49 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Endocarditis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected707 at risk EG0014 events4 affected348 at risk EG0020 events0 affected49 at risk EG003
Gangrene	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0012 events2 affected348 at risk EG0020 events0 affected49 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Graft infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Groin abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Hepatic cyst infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0004 events3 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0006 events6 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Hypertensive encephalopathy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Hypotension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
International normalised ratio decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
International normalised ratio increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Leriche syndrome	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Medical device complications	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0013 events3 affected348 at risk EG0020 events0 affected49 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Nephrectomy	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0012 events2 affected348 at risk EG0020 events0 affected49 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0021 events1 affected49 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0013 events3 affected348 at risk EG0020 events0 affected49 at risk EG003
Peritonitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Peritonitis bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Pneumonia	Infections and infestations		Systematic Assessment	EG0007 events7 affected707 at risk EG0012 events2 affected348 at risk EG0020 events0 affected49 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Renal cyst infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Renal transplant	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0021 events1 affected49 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0005 events4 affected707 at risk EG0013 events3 affected348 at risk EG0020 events0 affected49 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Shunt infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Syncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0012 events2 affected348 at risk EG0020 events0 affected49 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Thrombosis in device	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0012 events2 affected348 at risk EG0020 events0 affected49 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0004 events3 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Wound complication	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Toxic encelphalopathy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0010 events0 affected348 at risk EG0020 events0 affected49 at risk EG003
Mental impairment	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0010 events0 affected348 at risk EG0021 events1 affected49 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0010 events0 affected348 at risk EG0021 events1 affected49 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected707 at risk EG0010 events0 affected348 at risk EG0021 events1 affected49 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDra (13.1)	Systematic Assessment	EG000184 events142 affected707 at risk EG00131 events26 affected348 at risk EG0021 events1 affected49 at risk EG0031 events1 affected45 at risk
Faeces discoloured	Gastrointestinal disorders	MedDra (13.1)	Systematic Assessment	EG000110 events109 affected707 at risk EG0011 events1 affected348 at risk EG0020 events0 affected49 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDra (13.1)	Systematic Assessment	EG000114 events79 affected707 at risk EG00139 events27 affected348 at risk EG0027 events7 affected49 at risk EG003
Nausea	Gastrointestinal disorders	MedDra (13.1)	Systematic Assessment	EG00060 events51 affected707 at risk EG00141 events39 affected348 at risk EG0020 events0 affected49 at risk EG003
Hypertension	Vascular disorders	MedDra (13.1)	Systematic Assessment	EG00054 events45 affected707 at risk EG00139 events26 affected348 at risk EG0020 events0 affected49 at risk EG003
Vomiting	Gastrointestinal disorders	MedDra (13.1)	Systematic Assessment	EG00036 events31 affected707 at risk EG00122 events19 affected348 at risk EG0020 events0 affected49 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDra (13.1)	Systematic Assessment	EG00025 events23 affected707 at risk EG0017 events7 affected348 at risk EG0023 events3 affected49 at risk EG003
Constipation	Gastrointestinal disorders	MedDra (13.1)	Systematic Assessment	EG00033 events27 affected707 at risk EG00126 events25 affected348 at risk EG0020 events0 affected49 at risk EG003

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