Randomized Study Comparing Genz-644470, Placebo, and Seve... | NCT00853242 | Trialant
NCT00853242
Sponsor
Genzyme, a Sanofi Company
Status
Completed
Last Update Posted
May 1, 2015Estimated
Enrollment
349Actual
Phase
Phase 2
Conditions
Kidney Failure, Chronic
Interventions
Placebo
Genz-644470
Sevelamer carbonate
Countries
United States
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT00853242
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
APB00108
Secondary IDs
Not provided
Brief Title
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis
Acronym
LEAP
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Apr 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2009
Primary Completion Date
Aug 2009Actual
Completion Date
Aug 2009Actual
First Submitted Date
Feb 27, 2009
First Submission Date that Met QC Criteria
Feb 27, 2009
First Posted Date
Mar 2, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 15, 2015
Results First Submitted that Met QC Criteria
Apr 15, 2015
Results First Posted Date
May 1, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 2, 2010
Certification/Extension First Submitted that Passed QC Review
Oct 2, 2010
Certification/Extension First Posted Date
Oct 5, 2010Estimated
Last Update Submitted Date
Apr 15, 2015
Last Update Posted Date
May 1, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genzyme, a Sanofi CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.
Detailed Description
Not provided
Conditions Module
Conditions
Kidney Failure, Chronic
Keywords
Chronic Kidney Disease
Phosphate Binder
Phosphate
Hyperphosphatemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
349Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
Drug: Placebo
Genz-644470 2.4 Grams Per Day (g/day)
Experimental
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Genz-644470 4.8 g/day
Experimental
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Genz-644470 7.2 g/day
Experimental
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Sevelamer Carbonate 2.4 g/day
Active Comparator
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Sevelamer Carbonate 4.8 g/day
Active Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Placebo
Genz-644470
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Baseline, Day 22
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
Baseline, Day 22
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Baseline, Day 22
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
Men or women 18 years or older
Exclusion Criteria:
Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 670 participants were screened of which 321 were screen failure and 349 participants were randomized. After screening, participants entered a two-week phosphate binder washout period prior to randomization.
Recruitment Details
The study was conducted at 64 centers in the United States between 11 February 2009 and 20 August 2009.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
FG001
Genz-644470 2.4 Grams Per Day (g/Day)
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Sevelamer Carbonate 7.2 g/day
Active Comparator
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Drug
Genz-644470 2.4 Grams Per Day (g/day)
Genz-644470 4.8 g/day
Genz-644470 7.2 g/day
Sevelamer carbonate
Drug
Sevelamer Carbonate 2.4 g/day
Sevelamer Carbonate 4.8 g/day
Sevelamer Carbonate 7.2 g/day
Renvela®
Change From Baseline in Total Cholesterol at Day 22
Baseline, Day 22
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
Baseline, Day 22
Birmingham
Alabama
United States
Hot Springs
Arkansas
United States
Bakersfield
California
United States
Los Angeles
California
United States
Paramount
California
United States
Pembroke Pines
California
United States
Porterville
California
United States
Riverside
California
United States
San Dimas
California
United States
Whittier
California
United States
Denver
Colorado
United States
Washington D.C.
District of Columbia
United States
Hudson
Florida
United States
Ocala
Florida
United States
Tampa
Florida
United States
Augusta
Georgia
United States
Marietta
Georgia
United States
Gurnee
Illinois
United States
Indianapolis
Indiana
United States
Wichita
Kansas
United States
Lexington
Kentucky
United States
Bethesda
Maryland
United States
Pontiac
Michigan
United States
Southfield
Michigan
United States
Brookhaven
Mississippi
United States
Gulfport
Mississippi
United States
St Louis
Missouri
United States
Kearney
Nebraska
United States
Las Vegas
Nevada
United States
Bellmore
New York
United States
Brooklyn
New York
United States
Buffalo
New York
United States
New York
New York
United States
Port Washington
New York
United States
The Bronx
New York
United States
Asheville
North Carolina
United States
Cincinnati
Ohio
United States
Doylestown
Pennsylvania
United States
Lancaster
Pennsylvania
United States
Lewistown
Pennsylvania
United States
Philadelphia
Pennsylvania
United States
Charleston
South Carolina
United States
Orangeburg
South Carolina
United States
Sumter
South Carolina
United States
Columbia
Tennessee
United States
Knoxville
Tennessee
United States
Nashville
Tennessee
United States
Houston
Texas
United States
Alexandria
Virginia
United States
Glendale
Wisconsin
United States
Milwaukee
Wisconsin
United States
San Juan
Puerto Rico
FG002
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
FG003
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
FG004
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
FG005
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
FG006
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
FG00050 subjects
FG00150 subjects
FG00249 subjects
FG00350 subjects
FG00450 subjects
FG00551 subjects
FG00649 subjects
Treated
FG00050 subjects
FG00149 subjects
FG00248 subjects
FG00350 subjects
FG00450 subjects
FG00551 subjects
FG00648 subjects
COMPLETED
FG00047 subjects
FG00147 subjects
FG00246 subjects
FG00346 subjects
FG00446 subjects
FG00549 subjects
FG00644 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0052 subjects
FG0065 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0043 subjects
FG0051 subjects
FG0061 subjects
Noncompliant
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0034 subjects
FG004
Other
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Safety Set included all randomized participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
BG001
Genz-644470 2.4 g/Day
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
BG002
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
BG003
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
BG004
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
BG005
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
BG006
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00050
BG00149
BG00248
BG00350
BG00450
BG00551
BG00648
BG007346
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.1± 13.6
BG00158.3± 12.0
BG00254.7± 11.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00124
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0012
BG002
Serum Phosphorus Level
Number
participants
Title
Denominators
Categories
less than (<) 7.0 milligram per deciliter (mg/dL)
Title
Measurements
BG00022
BG00122
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 From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (<=) 3 days after date of last study drug.
Posted
Mean
Standard Deviation
mg/dL
Baseline, Day 22
ID
Title
Description
OG000
Placebo
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
OG001
Genz-644470 2.4 g/Day
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
OG002
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG003
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Units
Counts
Participants
OG00050
OG00148
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.0± 1.3
OG001-0.6± 1.5
OG002-1.2± 1.6
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis was performed using Wilcoxon rank sum tests.
Wilcoxon Rank Sum Tests
0.0249
2-Sided
No
Superiority or Other
OG000
OG002
Analysis was performed using Wilcoxon rank sum tests.
Wilcoxon Rank Sum Tests
Secondary
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
FAS included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure <= 3 days after date of last study drug.
Posted
Mean
Standard Deviation
mg/dL
Baseline, Day 22
ID
Title
Description
OG000
Genz-644470 2.4 g/Day
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
OG001
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG002
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
OG003
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
OG004
Sevelamer Carbonate 4.8 g/Day
Secondary
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Full Analysis Set.
Posted
Mean
Standard Deviation
mg^2/dL^2
Baseline, Day 22
ID
Title
Description
OG000
Placebo
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
OG001
Genz-644470 2.4 g/Day
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
OG002
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG003
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
OG004
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Secondary
Change From Baseline in Total Cholesterol at Day 22
Full Analysis Set.
Posted
Mean
Standard Deviation
mg/dL
Baseline, Day 22
ID
Title
Description
OG000
Placebo
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
OG001
Genz-644470 2.4 g/Day
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
OG002
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG003
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
OG004
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Secondary
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
Full Analysis Set.
Posted
Mean
Standard Deviation
mg/dL
Baseline, Day 22
ID
Title
Description
OG000
Placebo
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
OG001
Genz-644470 2.4 g/Day
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
OG002
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG003
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
OG004
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Time Frame
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Description
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
4
50
17
50
EG001
Genz-644470 2.4 g/Day
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
2
49
17
49
EG002
Genz-644470 4.8 g/Day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
6
48
17
48
EG003
Genz-644470 7.2 g/Day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
6
50
25
50
EG004
Sevelamer Carbonate 2.4 g/Day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
8
50
22
50
EG005
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
5
51
25
51
EG006
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
5
48
22
48
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG0030 affected50 at risk
EG0040 affected50 at risk
EG0051 affected51 at risk
EG0060 affected48 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Asthenia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous graft site abscess
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Catheter bacteraemia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Gangrene
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Sepsis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Septic shock
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous fistula thrombosis
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous graft site haemorrhage
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous graft thrombosis
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Syncope
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Renal transplant
Surgical and medical procedures
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Malignant hypertension
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG0030 affected50 at risk
EG0041 affected50 at risk
EG0050 affected51 at risk
EG0060 affected48 at risk
Monocytosis
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Congenital cystic kidney disease
Congenital, familial and genetic disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Hyperparathyroidism secondary
Endocrine disorders
MedDRA 12.0
Systematic Assessment
EG0002 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Cataract
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Glaucoma
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0012 affected49 at risk
EG0020 affected48 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 affected50 at risk
EG0011 affected49 at risk
EG0021 affected48 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 affected50 at risk
EG0013 affected49 at risk
EG0023 affected48 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0022 affected48 at risk
EG003
Asthenia
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Catheter related complication
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Catheter site swelling
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Chills
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Face oedema
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0022 affected48 at risk
EG003
Oedema
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Oedema peripheral
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Pyrexia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected48 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Catheter related infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Gingival infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Influenza
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Localised infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0022 affected48 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous fistula thrombosis
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous graft aneurysm
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Arteriovenous graft thrombosis
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected48 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Procedural headache
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Vascular graft complication
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Heart rate irregular
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Weight increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0002 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0021 affected48 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0012 affected49 at risk
EG0020 affected48 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Migraine
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Depression
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0023 affected48 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0021 affected48 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Hypocapnia
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0021 affected48 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0020 affected48 at risk
EG003
Hot flush
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0010 affected49 at risk
EG0021 affected48 at risk
EG003
Hypertension
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0001 affected50 at risk
EG0011 affected49 at risk
EG0021 affected48 at risk
EG003
Hypotension
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 affected50 at risk
EG0011 affected49 at risk
EG0020 affected48 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Trial Transparency Team
Sanofi
Contact-US@sanofi.com
ID
Term
D007676
Kidney Failure, Chronic
D051436
Renal Insufficiency, Chronic
D054559
Hyperphosphatemia
Ancestor Terms
ID
Term
D051437
Renal Insufficiency
D007674
Kidney Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D010760
Phosphorus Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069603
Sevelamer
Ancestor Terms
ID
Term
D011073
Polyamines
D000588
Amines
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0062 subjects
0 subjects
FG0051 subjects
FG0062 subjects
56.7
± 13.3
BG00454.6± 13.4
BG00556.6± 11.9
BG00653.6± 13.1
BG00756.2± 12.7
23
BG00319
BG00422
BG00521
BG00615
BG007144
Male
BG00030
BG00125
BG00225
BG00331
BG00428
BG00530
BG00633
BG007202
1
BG0031
BG0042
BG0050
BG0062
BG0078
Black or African American
Title
Measurements
BG00021
BG00120
BG00225
BG00325
BG00423
BG00525
BG00622
BG007161
White
Title
Measurements
BG00029
BG00127
BG00222
BG00322
BG00425
BG00525
BG00623
BG007173
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0032
BG0040
BG0051
BG0061
BG0074
21
BG00321
BG00422
BG00520
BG00617
BG007145
Greater Than or Equal to (>=) 7.0 mg/dL
Title
Measurements
BG00028
BG00127
BG00227
BG00329
BG00428
BG00531
BG00631
BG007201
46
-1.8
± 1.9
0.0001
2-Sided
No
Superiority or Other
OG000
OG003
Analysis was performed using Wilcoxon rank sum tests.
Wilcoxon Rank Sum Tests
<0.0001
2-Sided
No
Superiority or Other
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG005
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Units
Counts
Participants
OG00048
OG00147
OG00246
OG00349
OG00448
OG00547
Title
Denominators
Categories
Title
Measurements
OG000-0.6± 1.5
OG001-1.2± 1.6
OG002-1.8± 1.9
OG003-0.9± 1.7
OG004-1.3± 1.9
OG005-2.0± 1.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Analysis was performed using Wilcoxon rank sum tests.
Wilcoxon Rank Sum Tests
0.2647
2-Sided
No
Superiority or Other
OG001
OG004
Analysis was performed using Wilcoxon rank sum tests.
Wilcoxon Rank Sum Tests
0.7944
2-Sided
No
Superiority or Other
OG002
OG005
Analysis was performed using Wilcoxon rank sum tests.
Wilcoxon Rank Sum Tests
0.3724
2-Sided
No
Superiority or Other
OG005
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG006
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Units
Counts
Participants
OG00050
OG00148
OG00247
OG00346
OG00449
OG00548
OG00647
Title
Denominators
Categories
Title
Measurements
OG000-0.1± 12.7
OG001-4.5± 12.3
OG002-9.2± 14.7
OG003-16.1± 16.1
OG004-8.3± 17.4
OG005-10.3± 17.5
OG006-17.5± 13.4
OG005
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG006
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Units
Counts
Participants
OG00050
OG00148
OG00247
OG00346
OG00449
OG00548
OG00647
Title
Denominators
Categories
Title
Measurements
OG000-3.8± 20.9
OG001-13.5± 20.7
OG002-11.2± 19.7
OG003-17.8± 22.8
OG004-2.9± 17.1
OG005-15.8± 16.3
OG006-18.1± 27.8
OG005
Sevelamer Carbonate 4.8 g/Day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
OG006
Sevelamer Carbonate 7.2 g/Day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.