Table 3.
Adverse events
| Possibly related | 73 (21.0 per 100 patient‐years) | |
| Cutaneous lesions | 23 | |
| Infusion related | 10 | |
| Arthralgia | 6 | |
| Headache | 8 | |
| Respiratory | 3 | |
| Other | 3 | |
| GI | 2 | |
| Exacerbation IBD | 2 | |
| Cardiac event | 2 | |
| Kidney/urinary tract | 2 | |
| Dizziness | 2 | |
| Malignancy | 2 | |
| Psychiatric | 2 | |
| Vascular | 2 | |
| Eye condition | 1 | |
| Fatigue | 1 | |
| Itch | 1 | |
| Transient tingling sensation | 1 | |
| Probably related | 20 (5.8 per 100 patient‐years) | |
| Infusion related | 8 | |
| Cutaneous lesions | 5 | |
| Arthralgia | 2 | |
| Nervous system | 2 | |
| Headache | 1 | |
| Dizziness | 1 | |
| Muscle cramp | 1 | |
| Serious adverse events | 10 (2.9 per 100 patient‐years) | |
| Arthralgia | 4 | |
| Infusion reaction | 2 | |
| Infusion related | 2 | |
| Headache | 1 | |
| GI infection | 1 | |
| Mild infections | 78 (22.5 per 100 patient‐years) | |
| Upper respiratory | 38 | |
| Flu‐like syndrome | 16 | |
| GI | 10 | |
| Fever (no focus) | 7 | |
| Cutaneous lesions | 3 | |
| Herpes zoster | 2 | |
| Soft tissue | 1 | |
| Cold sore | 1 | |
| Moderate infections | 42 (12.1 per 100 patient‐years) | |
| Upper respiratory | 15 | |
| GI | 6 | |
| Other | 5 | |
| Urinary tract | 4 | |
| Cutaneous lesions | 3 | |
| Pneumonia | 3 | |
| Herpes zoster | 2 | |
| Eye infection | 1 | |
| Gynecological | 1 | |
| Fever (no focus) | 1 | |
| Jaw/teeth | 1 | |
| Severe infections | 13 (3.7 per 100 patient‐years) | |
| GI | 5 | |
| Pneumonia | 5 | |
| Upper respiratory | 1 | |
| Other | 1 | |
| Musculoskeletal inflammation | 1 |
Adverse events during vedolizumab treatment (mild: no antibiotics or antiviral medication, moderate: oral antibiotics or antiviral medication, severe: hospitalization or intravenously administrated antibiotics or antiviral medication).
GI, gastrointestinal; IBD, inflammatory bowel disease.