Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited patients were male or female with end-stage renal failure aged 50 to 80 years, who had received regular chronic haemodialysis treatment (including haemofiltration and hemodiafiltration ) for at least 3 months. They were recruited from 280 sites in 25 countries; recruitment started on 16 January 2003 and finished on 24 November 2004.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a two week screening period, eligible patients were randomly assigned to either rosuvastatin treatment (10mg/day) or placebo with a 1:1 randomisation ratio. Follow-up was planned to continue until the accrual of 805 major cardiovascular events

Reporting Groups

	Description
Rosuvastatin 10mg	Rosuvastatin 10 mg oral tablets
Placebo	Matching placebo

Participant Flow:   Overall Study

	Rosuvastatin 10mg	Placebo
STARTED	1389 [1]	1384 [2]
COMPLETED	1263 [3]	1250 [3]
NOT COMPLETED	126	134
Withdrawal by Subject	125	132
Option selected by investigator	1	2

Reporting Groups

	Description
Rosuvastatin 10mg	Rosuvastatin 10 mg oral tablets
Placebo	Matching placebo

Baseline Measures

	Rosuvastatin 10mg	Placebo	Total
Number of Participants   [units: participants]	1389	1384	2773
Age   [units: Years] Mean ± Standard Deviation	64.1  ± 8.6	64.3  ± 8.7	64.2  ± 8.6
Gender   [units: Participants]
Female	538	512	1050
Male	851	872	1723

1.  Primary:

Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]

2.  Secondary:

Number of Randomised Participants That Died From Any Cause.   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]

3.  Secondary:

Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]

4.  Secondary:

Number of Randomised Participants That Died From Cardiovascular Cause   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]

5.  Secondary:

Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]

6.  Secondary:

Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]

7.  Secondary:

Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]

8.  Secondary:

Number of Randomised Participants That Died From Non Cardiovascular Cause   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]