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 event | 50 (79) | 41 (64) |
| Infections and infestations | 24 (38) | 20 (31) |
| Gastrointestinal disorders | 10 (16) | 14 (22) |
| Nervous system disorders | 14 (22) | 13 (20) |
| Musculoskeletal and connective tissue disorders | 8 (13) | 9 (14) |
| General disorders and administration site conditions | 5 (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.