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Table 1 Demographic and clinical characteristics at baseline

From: Randomised, double-blind, placebo-controlled trial of oral budesonide for prophylaxis of acute intestinal graft-versus-host disease after allogeneic stem cell transplantation (PROGAST)

Characteristic

Budesonide (N = 48)

Placebo (N = 43)

p Value

Male sex - no. (%)

30 (62.5)

29 (67.4)

0.662

0.662 Median age (yrs) - Mean (SD)

53.1 + 12.2

52.0 + 12.9

0.660*

Duration of disease (mths) -Mean (SD)

23.4 + 33.4

15.4 + 15.4

0.139*

Complete remission pre-SZT - no. (%)

18 (38.3)

17 (40.5)

0.834

Basic disease - no. (%)

  

0.179

Myelodysplastic syndrome - MDS

5 (10.6)

7 (16.3)

 

Acute myeloid leucemia - AML

19 (40.4)

14 (32.6)

 

Acute lymphoblastic leucemia - ALL

7 (14.6)

4 (9.3)

 

Chronic myeloid leucemia - CML

1 (2.1)

  

Chronic lymphocytic leucemia - CLL

1 (2.1)

2 (4.7)

 

Non Hodgkin lymphoma - NHL /M. Hodgkin

6 (12.8)

3 (7.0)

 

Multiple myeloma

3 (6.4)

11 (25.6)

 

Others

5 (10.6)

2 (4.7)

 

Chemotherapeutic conditioning - no. (%)

44 (91.7)

36 (83.7)

0.246

Total body irradiation -TBI - no. (%)

27 (56.3)

22 (51.2)

0.627

Dosage reduced induction regimen (%)

27 (56.3)

24 (55.8)

0.967

In-vivo T-cell depletion (%)

29 (60.4)

26 (60.5)

0.994

Sibling transplant (%)

17 (35.4)

15 (34.9)

0.958

CMV-status positive - no. (%)

31 (64.6)

32 (74.4)

0.31

  1. 0.31P value based on a chi-square test or * t-test.