Eight patients had 10 SAEs in the vedolizumab group considered as treatment related by the study investigator (n = 1 patient each for ventricular tachycardia, aGVHD of the intestine, chronic GVHD, Escherichia bacteremia, pneumonia, pseudomonal pneumonia, viral meningitis, subdural hematoma, increased alanine aminotransferase, and recurrent chronic myeloid leukemia). This evidence concerns the gene GPT and Pseudomonas infection.