Table 2:
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