Table 3

Most commonly reported (≥3 participants) treatment-emergent adverse events: safety population

MedDRA system organ class*Placebo (n=63)Vedolizumab (n=64)
Participants with ≥1 adverse event50 (79)41 (64)
Infections and infestations24 (38)20 (31)
Gastrointestinal disorders10 (16)14 (22)
Nervous system disorders14 (22)13 (20)
Musculoskeletal and connective tissue disorders8 (13)9 (14)
General disorders and administration site conditions5 (8)6 (9)
  • Values are n (%).

  • The safety population was defined as all participants who received any amount of study drug (vedolizumab or placebo) based on what they actually received.

  • *A participant was counted only once in each system organ class.

  • MedDRA, Medical Dictionary for Regulatory Activities.