Prospective Evaluation of Proteinuria and Renal Function... | NCT00296374

ID	Type	Description	Link
PLANET 1

Official Title

Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Rosuvastatin 10 mg	Drug: Rosuvastatin
2	Experimental	Rosuvastatin 40 mg	Drug: Rosuvastatin
3	Active Comparator	Atorvastatin 80 mg	Drug: Atorvastatin

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	10 mg oral dose administered once daily for 52 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.	Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.	Assessed at Week 52, Last observation carried forward (LOCF)

Secondary Outcomes

Measure	Description	Time Frame
Urinary Protein/Creatinine Ratio at Week 26.	Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.	Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 26

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
AstraZeneca Crestor Medical Science Director, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Avondale	Arizona		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38018702	Derived	Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
25660356	Derived

Results Section

Participant Flow Module

ID	Title	Description
FG000	Rosuvastatin 10mg
FG001	Rosuvastatin 40mg
FG002	Atorvastatin 80mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

18-49 years

Title	Measurements
	BG00022 BG00133 BG00225 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00043 BG00132 BG002

Estimated glomerular filtration rate [eGFR]

Mean

Standard Deviation

mL/min

Title

Denominators

Categories

Title	Measurements
	BG00068.759± 24.1080 BG00172.644± 25.8018 BG002

Urine albumin/creatinine ratio

Mean

Standard Deviation

mg/g

Title

Denominators

Categories

Title	Measurements
	BG0001036.478± 730.6185 BG0011079.802± 725.7039 BG002

Urine protein/creatinine ratio

Mean

Standard Deviation

mg/g

Title

Denominators

Categories

Title	Measurements
	BG0001392.26± 888.3215 BG0011493.574± 996.0972 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

Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.

Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.

Posted

Geometric Mean

95% Confidence Interval

mg/g

Assessed at Week 52, Last observation carried forward (LOCF)

ID	Title	Description
OG000	Rosuvastatin 10mg
OG001	Rosuvastatin 40mg
OG002	Atorvastatin 80mg

Units	Counts
Participants	OG000107 OG001116 OG002102

Title

Denominators

Categories

Title	Measurements
	OG0001.016(0.858 to 1.209) OG0010.955(0.869 to 1.185) OG0020.874(0.733 to 0.975)

Secondary

Urinary Protein/Creatinine Ratio at Week 26.

Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.

Posted

Geometric Mean

95% Confidence Interval

mg/g

Assessed at Week 26

ID	Title	Description
OG000	Rosuvastatin 10mg
OG001	Rosuvastatin 40mg
OG002	Atorvastatin 80mg

Units	Counts
Participants	OG000

Secondary

Urinary Albumin/Creatinine Ratio at Week 26

Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.

Posted

Geometric Mean

95% Confidence Interval

mg/g

Assessed at Week 26

ID	Title	Description
OG000	Rosuvastatin 10mg
OG001	Rosuvastatin 40mg
OG002	Atorvastatin 80mg

Units	Counts
Participants	OG000

Secondary

Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]

Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.

Posted

Geometric Mean

95% Confidence Interval

mg/g

Assessed at Week 52 LOCF

ID	Title	Description
OG000	Rosuvastatin 10mg
OG001	Rosuvastatin 40mg
OG002	Atorvastatin 80mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26

Posted

Mean

Standard Deviation

mL/min

Assessed at Baseline and Week 26

ID	Title	Description
OG000	Rosuvastatin 10mg
OG001	Rosuvastatin 40mg
OG002	Atorvastatin 80mg

Units	Counts
Participants	OG000100

Secondary

Change From Baseline in eGFR at Week 52 [LOCF]

Posted

Mean

Standard Deviation

mL/min

Assessed at Baseline and Week 52 [LOCF]

ID	Title	Description
OG000	Rosuvastatin 10 mg
OG001	Rosuvastatin 40 mg
OG002	Atorvastatin 80 mg

Units	Counts
Participants	OG000107

Secondary

Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

Assessed at 52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio

Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio

Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and TC

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and TC

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 Weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and TG

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and TG

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.

Posted

Number

Correlation coefficient

26 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Secondary

Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio

Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52

Posted

Number

Correlation coefficient

52 weeks

ID	Title	Description
OG000	Rosuvastatin	Rosuvastatin Treatments pooled
OG001	Atorvastatin	Atorvastatin Treatment
OG002	All Treatment	All Treatments pooled

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rosuvastatin 10mg	18	116	15	116
EG001	Rosuvastatin 40mg	20	123	25	123
EG002	Atorvastatin 80mg	21	110	12	110

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac Failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected116 at risk EG0011 affected123 at risk EG0021 affected110 at risk
Angina Pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected116 at risk EG0011 affected123 at risk EG0022 affected110 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Angina Unstable	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Cataract	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Diabetic Eye Disease	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Vitreous Haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Diabetic Retinopathy	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Intestinal Polyp	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Oedema Peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Death	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Soft Tissue Inflammation	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Sudden Death	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Chest Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Gangrene	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0021 affected110 at risk
Osteomyelitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Skin Infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Pyelonephritis Chronic	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Abdominal Infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Abscess Limb	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0022 affected110 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0021 affected110 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Aphasia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Presyncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Syncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0022 affected110 at risk
Factitious Disorder	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0012 affected123 at risk EG0020 affected110 at risk
Diabetic Nephropathy	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Renal Failure	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0011 affected123 at risk EG0020 affected110 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Pickwickian Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected116 at risk EG0010 affected123 at risk EG0020 affected110 at risk
Femoral Arterial Stenosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk
Poor Peripheral Circulation	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected116 at risk EG0010 affected123 at risk EG0021 affected110 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oedema Peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0009 affected116 at risk EG0015 affected123 at risk EG0023 affected110 at risk
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 affected116 at risk EG0017 affected123 at risk EG0020 affected110 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected116 at risk EG0016 affected123 at risk EG0027 affected110 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected116 at risk EG0018 affected123 at risk EG0022 affected110 at risk

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011758	Pyrroles
D001393	Azoles
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids

ID	Title	Description
BG000	Rosuvastatin 10mg
BG001	Rosuvastatin 40mg
BG002	Atorvastatin 80mg
BG003	Total	Total of all reporting groups

ID	Term
D003920	Diabetes Mellitus
D006949	Hyperlipidemias
D011507	Proteinuria