Table 4.
Adverse Event | UC (n = 147) | CD (n = 127) | Total |
---|---|---|---|
Infusion reaction and hypersensitivity | 2 (1.4) | 0 (0) | 2 (0.7) |
HBV reactivation | 0 (0) | 1 (0.8) | 1 (0.4) |
HCV reactivation | 0 (0) | 0 (0) | 0 (0) |
TB reactivation | 0 (0) | 0 (0) | 0 (0) |
Upper respiratory tract infection | 0 (0) | 1 (0.8) | 1 (0.4) |
Gastrointestinal tract infection | 0 (0) | 2 (1.6) | 2 (0.7) |
Others | |||
Hair loss | 0 (0) | 1 (0.8) | 1 (0.4) |
Headache | 1 (0.7) | 0 (0) | 1 (0.4) |
SAE | |||
Pneumonia | 0 (0) | 0 (0) | 0 (0) |
Opportunistic infection | 0 (0) | 1 (0.8) | 1 (0.4) |
Intractable infection | 0 (0) | 1 (0.8) | 1 (0.4) |
Intra-abdominal abscess | 0 (0) | 1 (0.8) | 1 (0.4) |
Intestinal perforation | 1 (0.7) | 0 (0) | 1 (0.4) |
Malignancy | 0 (0) | 0 (0) | 0 (0) |
Mortality | 0 (0) | 0 (0) | 0 (0) |
Values are n (%).
Abbreviations: CD, Crohn’s disease; HBV, hepatitis B virus; HCV, hepatitis C virus; SAE, serious adverse event; TB, tuberculosis; UC, ulcerative colitis; VDZ, vedolizumab.