A phase3 Study Measuring the Effect of Rosuvastatin 20 mg... | NCT02546323

Label	Type	Description	Intervention Names
Rosuvastatin	Experimental	20 mg tablets, Daily oral dose	Drug: Rosuvastatin
Placebo	Placebo Comparator	Matching placebo tablets	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	20mg tablets, orally once daily for the duration of the 104-week treatment period	Rosuvastatin

Measure	Description	Time Frame
Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period	CIMT measurements were made from ultrasound images of the common carotid artery (CCA), carotid bulb and internal carotid artery (ICA). The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. Twelve carotid artery sites were scanned at each visit and the 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for a specific segment. The annualized rate of change in the MeanMax CIMT measurements from each of the 12 sites, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.	From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).

Measure	Description	Time Frame
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA	CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of informed consent prior to any study-specific procedures
Male aged ≥45 and <70 years or female aged ≥55 and <70 years
Subjects with only hypertension (as defined blood pressure ≥140/90 mmHg or on antihypertensive treatment) and age as CVD risk factors and subjects without hypertension who have 3 or more other risk factors (including age) must have "Fasting LDL C of ≥120 mg/dL (3.1 mmol/L) and <160 mg/dL (4.1mmol/L)"; Subjects without hypertension who have fewer than 3 other risk factors (including age) must have "Fasting LDL-C of ≥120 mg/dL (3.1 mmol/L) and <190 mg/dL (4.9 mmol/L)"
Triglycerides <500 mg/dL (5.65 mmol/L) at Visit 1
HDL-C levels ≤60 mg/dL (1.6 mmol/L) at Visit 1
Maximum IMT ≥1.2 mm and <3.5 mm at any location in the carotid ultrasound scans conducted at both Visit 2 and Visit 3
Willing to follow all study procedures including study visits, fasting blood draws, and compliance with study treatment regimen

Exclusion Criteria:

Use of pharmacologic lipid-lowering medications (eg, statins, fibrate derivatives,bile acid binding resins, niacin, or its analogues at doses >400 mg or prescribed Chinese traditional drugs), including cholesterol-absorption inhibitors (CAIs), and CAI/statin combination, within 12 months prior to Visit 1
Current or recent (within 2 weeks of Visit 1) use of supplements known to alter lipid metabolism (eg, soluble fibers [including >2 teaspoons Metamucil® or psyllium-containing supplement per day] or other dietary fiber supplements, marine oils, sterol/stanol products, or other supplement determined at the discretion of the investigator)
History of hypersensitivity reactions to other HMG-CoA reductase inhibitors
Pregnant women, women who are breast-feeding, and women of childbearing potential who are not using chemical or mechanical contraception or who have a positive serum pregnancy test
Clinical evidence of coronary artery disease (CAD) or any other atherosclerotic disease such as angina, MI, transient ischemic attack, symptomatic CAD, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, peripheral arterial disease, abdominal aortic aneurysm
History of cancer (other than basal cell carcinoma) in the past 2 years
Uncontrolled hypertension defined as either a mean resting diastolic blood pressure of ≥110 mmHg or a resting systolic blood pressure of ≥180 mmHg recorded at any time during the screening period
History of diabetes mellitus or current diabetes mellitus
Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH) >1.5 times the upper limit of normal (ULN) at Visit 1 or subjects whose thyroid replacement therapy was initiated within the last 3 months
History of heterozygous or homozygous familial hypercholesterolemia or known hyperlipoproteinemia Types I, III, IV, or V (familial dysbetalipoproteinemia)
Use of the disallowed concomitant medications within 12 months prior to Visit 1
History of alcohol and/or drug abuse within the past 5 years
Active liver disease or hepatic dysfunction as defined by elevations of ≥1.5 x ULN at Visit 1 in any of the following liver function tests: ALT, AST or bilirubin
Serum creatine kinase (CK) >3 x ULN at Visit 1
Serum creatinine >2.0 mg/dL (177 mmol/L) recorded during the screening period
Participation in another investigational drug study, and having ingested investigational drug ≤4 weeks before enrollment in the screening period
Previous randomization in the present study
History of a significant medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)

Name	Affiliation	Role
Yongjun Wang, M.D.	Beijing Tian Tan Hospital, Capital Medical University	Principal Investigator
Yundai Chen, M.D.	Chinese PLA General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Beijing		100035	China
Research Site

PubMed Identifier	Type	Citation	Retractions
37565307	Derived	Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
36017704	Derived	Zheng H, Li H, Wang Y, Li Z, Hu B, Li X, Fu L, Hu H, Nie Z, Zhao B, Wei D, Karlson BW, Bots ML, Meng X, Chen Y, Wang Y; METEOR-China Investigators. Rosuvastatin Slows Progression of Carotid Intima-Media Thickness: The METEOR-China Randomized Controlled Study. Stroke. 2022 Oct;53(10):3004-3013. doi: 10.1161/STROKEAHA.120.031877. Epub 2022 Aug 26.

Label	URL
redacted protocol	View source

ID	Title	Description
FG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
FG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 28, 2018	Nov 25, 2019

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

Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period

CIMT measurements were made from ultrasound images of the common carotid artery (CCA), carotid bulb and internal carotid artery (ICA). The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. Twelve carotid artery sites were scanned at each visit and the 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for a specific segment. The annualized rate of change in the MeanMax CIMT measurements from each of the 12 sites, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.

The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.

Posted

Mean

Standard Error

mm/year

From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).

ID	Title	Description
OG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
OG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.

Units	Counts
Participants	OG000272 OG001271

Title

Denominators

Categories

Title	Measurements
	OG0000.0038± 0.00312 OG0010.0142± 0.00317

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	Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.	Multi-level mixed effects model		0.020	Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.	Estimated mean difference	-0.0103	Standard Error of the Mean	0.00445	2-Sided	95	-0.0191	-0.0016			Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.

Secondary

Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA

CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.

The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.

Posted

Mean

Standard Error

mm/year

From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).

ID	Title	Description
OG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
OG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.

Secondary

Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb

CIMT measurements were made from ultrasound images of the near and far walls of the right and left carotid bulb. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.

The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.

Posted

Mean

Standard Error

mm/year

From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).

ID	Title	Description
OG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
OG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.

Secondary

Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA

CIMT measurements were made from ultrasound images of the near and far walls of the right and left ICA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.

The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.

Posted

Mean

Standard Error

mm/year

From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).

ID	Title	Description
OG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
OG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.

Secondary

Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA

CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the mean of the CIMT for this segment. The annualized rate of change in the MeanMean CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.

The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.

Posted

Mean

Standard Error

mm/year

From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).

ID	Title	Description
OG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
OG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.

Secondary

Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)

The percent change from baseline at final visit for lipid and lipoprotein measurements (low-density lipoprotein cholesterol [LDL-C], total cholesterol, high-density lipoprotein cholesterol [HDL-C], triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) and apolipoprotein measurements (apolipoprotein A-I [ApoA-I], apolipoprotein B [ApoB] and ApoB/ApoA-I ratio) was determined by analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0) to the final visit at Week 104, any missing observations were imputed by LOCF.

The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.

Posted

Least Squares Mean

Standard Error

Percent change

From baseline (Week 0) to end-of-study (Week 104).

ID	Title	Description
OG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
OG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.

Secondary

Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average

The percent change from baseline at final visit for lipid and lipoprotein measurements (LDL-C, total cholesterol, HDL-C, triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) was determined by ANCOVA with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0), the time-weighted average value was calculated as the value multiplied by the number of days since the last assessment, summed for all observations, and divided by the sum of days between all visits.

The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.

Posted

Least Squares Mean

Standard Error

Percent change

From baseline (Week 0) to end-of-study (Week 104).

ID	Title	Description
OG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
OG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0012 events2 affected268 at risk
Angina unstable	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0011 events1 affected268 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0012 events2 affected268 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Goitre	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0011 events1 affected268 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Thyroid mass	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected272 at risk EG0011 events1 affected268 at risk
Iridocyclitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Pathologic myopia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Pterygium	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Retinal detachment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Retinal vein occlusion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0011 events1 affected268 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Chronic sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Hepatitis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0012 events2 affected268 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0011 events1 affected268 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Investigation	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0012 events2 affected268 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected272 at risk EG0010 events0 affected268 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Cerebral artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected272 at risk EG0010 events0 affected268 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0010 events0 affected268 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Henoch-Schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Arterial thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected272 at risk EG0011 events1 affected268 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected272 at risk EG0011 events1 affected268 at risk

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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

ID	Title	Description
BG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
BG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rosuvastatin 20 mg	Rosuvastatin 20 mg was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.	0	272	38	272	144	272
EG001	Placebo	Placebo was administered in oral tablet form, once daily, for a 104-week (2-year) treatment period.	1	268	34	268	142	268

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Toothache	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00039 events23 affected272 at risk EG00123 events15 affected268 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00079 events52 affected272 at risk EG00177 events56 affected268 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00074 events49 affected272 at risk EG00171 events54 affected268 at risk
Blood glucose increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00024 events24 affected272 at risk EG00118 events18 affected268 at risk
Protein urine present	Investigations	MedDRA 21.0	Systematic Assessment	EG00016 events16 affected272 at risk EG00110 events9 affected268 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00017 events14 affected272 at risk EG00124 events16 affected268 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00018 events14 affected272 at risk EG00119 events15 affected268 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00019 events19 affected272 at risk EG00127 events21 affected268 at risk