Of these, 3 patients had 3 SAEs in the vedolizumab group that were considered as treatment related by the study investigator (pancytopenia, pyrexia, and bronchopulmonary aspergillosis), and 2 patients had 3 SAEs in the placebo group considered as treatment related (atypical mycobacterial infection, pneumonia, and increased alanine aminotransferase). Here, GPT is linked to pneumonia.