Skip to main content

Table 1 Baseline characteristics (FAS). The sequence groups did not show any relevant differences in terms of gender, age, height, or weight in the FAS or the PP analysis set

From: Randomized, open-label, comparative phase IV study on the bioavailability of Ciclosporin Pro (Teva) versus Sandimmun® Optoral (Novartis) under fasting versus fed conditions in patients with stable renal transplants

   fasting→fed fed→fasting Total
(n = 15) (n = 16) (n = 31)
Gender
 Male n (%) 10 (66.7%) 10 (62.5%) 20 (64.5%)
 Female n (%) 5 (33.3%) 6 (37.5%) 11 (35.5%)
Race 15 (100%) 16 (100%) 31 (100%)
 Caucasian n (%)
Age [years] Mean (SD) 48.5 (12.4) 49.9 (14.0) 49.3 (13.1)
Range 19–67 22–77 19–77
Weight [kg] Mean (SD) 77.8 (14.3) 78.8 (11.3) 78.3 (12.6)
Range 55–102 59–102 55–102
Height [cm] Mean (SD) 174.3 (11.6) 173.9 (14.6) 174.1 (13.0)
Range 160–200 143–200 143–200
BMI [kg/m2] Mean (SD) 25.5 (3.4) 26.3 (4.0) 25.9 (3.7)
Range 21.3–30.2 19.8–32.2 19.8–32.2
Smoking habits 9 (60.0%) 13 (81.3%) 22 (71.0%)
 Non-smoker n (%)
 Ex-smoker n (%) 3 (20.0%) 3 (9.7%)
 Smoker n (%) 1 (6.7%) 3 (18.8%) 4 (12.9%)
 Unknown n (%) 2 (13.3%) 2 (6.5%)
Time since last renal transplantation [years] Median (Range) 6.0 (2–28) 6.5 (1–24) 6.0 (1–28)
Number of previous rejection episodes
 0 n (%) 13 (86.7%) 11 (68.8%) 24 (77.4%)
 1 n (%) 1 (6.7%) 5 (31.3%) 6 (19.4%)
 2 n (%) 1 (6.7%) 1 (3.2%)
Time since end of last rejection episode [months] Median (Range) 36.1 (33–39) 23.7 (6–63) 36.1 (6–63)
[n = 2] [n = 4]a [n = 6]a
Duration of last rejection episode [days] Median (Range) 3.5 (3–4) 4.0 (3–7) 4.0 (3–7)
[n = 2] [n = 4]a [n = 6]a
Last daily ciclosporin dose applied before baseline [mg/kg/day] Mean (SD) 2.43 (0.707) 2.31 (0.560) 2.37 (0.628)
  1. a For one patient only year was given for start and end date of last rejection episode (1989). As a result, time since end and duration of last rejection were not assessable for this patient