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Artikel des Monats Oktober 2011

 

THE LANCENT

 

Supplementary webappendix
This webappendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. This online publication has been corrected. The corrected version first appeared at thelancet.com on June 10, 2011.Supplement to: Budde K, Becker T, Arns W, et al, on behalf of the ZEUS Study Investigators. Everolimus-based, calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants: an open-label, randomised, controlled trial. Lancet 2011; published online Feb 21, 2011. DOI:10.1016/S0140-6736(10)62318-5.
Supplementary Table 1. Reasons for discontinuations before and after randomisation

 

  Before randomisation After randomisation
 

Patients included
N=503

Ciclosporin (N=145)

Everolimus
(N=155)

Total Reason

203

28

37

Withdrew consent

51

3

9

Number of patients with adverse event*

43

3

10

Increased creatinine

14

1

Gastrointestinal disorders
Aphtae/Lip ulcer

8

1

4

2

Ciclosporin/drug toxicity
Hirsutism

7

3

Malignancy

3

1

1

Thrombotic
microangiopathy

2

Surgical and wound
complication

4

Renal and urinary disorders

7

1

Others

6

1

6

Rejection/unsatisfactory
therapeutic effect

37

5

6

Infection

18

5

5

CMV

7

1

BKV

4

1

Pneumonia

2

2

1

Herpes

2

1

Others

3

4

Graft loss

17

Protocol violation

15

2

4

Abnormal
laboratory value

10

3

Administrative problem

6

1

Lost to follow-up

3

8

Death

3

1

 

*Some patients experienced more than one adverse event

 

Supplementary Figure 1. Kaplan–Meier survival distribution function on the time to drop-out before randomisation at Month 4·5 for the non-randomised patient population.


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