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Table 3 Adverse events and serious adverse events

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)

Variable

Budesonide Budesonide (N = 48)

Placebo (N = 43)

P Value

Patients with any adverse event - no. (%)

48 (100.0)

42 (97.7)

nsa

Any serious adverse event - no. (%)

13 (27.1)

13 (30.2)

nsa

Infectious complications - no. (%)

   

Adverse event

23 (47.9)

13 (30.2)

0.085 (ns)a

Pneumonia

2 (4.2)

4 (9.3)

 

Sepsis

3 (6.3)

0 (0)

 

Serious adverse event

5 (10.4)

1 (2.3)

0.207 (ns)b

Pneumonia

2 (4.2)

1 (2.3)

 

Sepsis

2 (4.2)

0 (0)

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