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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)