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. Author manuscript; available in PMC: 2020 Feb 21.
Published in final edited form as: Clin Gastroenterol Hepatol. 2018 May 8;17(3):486–493. doi: 10.1016/j.cgh.2018.04.060

Table 2:

Adverse Events on Vedolizumab

Event Patients with inflammatory bowel disease (n=27)
Adverse event – Non-infectious
Neurological complaints (n=4) 4 Total
- 1 Paraesthesia
- 1 migraine
- 2 mild tremor
Pruritis 1 total
Rheumatological 2 Total
- 1 new onset arthralgia
- 1 leg cramps
Infusion related reaction 1 infusion reaction*
Cancer No cancer documented
Constipation 2 total
Perianal disease 1 Total
- 1 worsening perianal fistula
Fatigue 1 total
Oro-facial complications 1 total
- 1 gum sensitivity
Any serious non-infectious event* 1 total
Adverse event – Infections
Enteric infection 2 total
- 1 viral enteritis*
- 1 CMV and C. difficile colitis – colectomy*
Sino-pulmonary infections 1 sinusitis
Post-operative complications 2 total
  -  1 delayed perineal healing
  -  1 mucocutaneous separation of stoma
Miscellaneous 1 UTI
Any serious infection* 4 total
*

A serious adverse event or infection was defined as any adverse event when leading to treatment interruption, antibiotic therapy, hospitalization, disability or persistent damage, colectomy or death