Table 4.
Parameter | Ulcerative colitis (N = 894) | Crohn's disease (N = 1349) | ||
---|---|---|---|---|
n (%) | Incidence/1000 person‐years (95% CI) a | n (%) | Incidence/1000 person‐years (95% CI) a | |
Gastrointestinal infections of special interest | 122 (13.6) | 46.9 (38.3, 55.6) | 162 (12.0) | 46.1 (38.8, 53.4) |
Abdominal and gastrointestinal infections (pathogen unspecified) b | 92 (10.3) | 34.9 (27.6, 42.3) | 141 (10.5) | 39.6 (32.9, 46.3) |
Clostridium infections c | 26 (2.9) | 9.1 (5.6, 12.6) | 21 (1.6) | 5.4 (3.1, 7.8) |
Campylobacter infections d | 9 (1.0) | 3.1 (1.1, 5.2) | 8 (<1) | 2.1 (0.6, 3.5) |
Shigella infections e | 0 | 0 | 1 (<1) | 0.3 (0, 0.8) |
Yersinia infections f | 1 (<1) | 0.3 (0, 1.0) | 0 | 0 |
Bacterial infections (bacteria unspecified) g | 0 | 0 | 1 (<1) | 0.3 (0, 0.8) |
Abbreviation: CI, confidence interval; MedDRA, Medical Dictionary for Regulatory Activities.
Time‐adjusted incidence rate per 1000 person‐years = (number of patients experiencing an adverse event of interest/total person time in years) × 1000.
MedDRA preferred terms: gastroenteritis, diarrhoea infectious, gastrointestinal infection, enteritis infectious, enterocolitis infectious and gastric infection.
MedDRA preferred terms: Clostridium difficile colitis, Clostridial infection and Clostridium colitis.
MedDRA preferred terms: Campylobacter gastroenteritis, Campylobacter intestinal infection and Campylobacter infection.
MedDRA preferred term gastroenteritis shigella.
MedDRA preferred term gastroenteritis yersinia.
Bacterial infections represent MedDRA preferred term gastroenteritis bacterial.