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Table 1 Demographics and baseline characteristics (full analysis set)

From: Infliximab for pediatric patients with ulcerative colitis: a phase 3, open-label, uncontrolled, multicenter trial in Japan

Characteristic Number (%) or median (IQR)
(total n = 21)
Sex
 Male, n (%) 11 (52.4)
 Female, n (%) 10 (47.6)
Age (years), median (IQR) 14.0 (12.0, 15.0)
 6 to < 12 years, n (%) 4 (19.0)
 12 to 17 years, n (%) 17 (81.0)
Weight (kg), median (IQR) 45.40 (40.00, 54.50)
Height (cm), median (IQR) 158.0 (150.0, 162.0)
BMI (kg/m2), median (IQR) 17.78 (15.71, 19.55)
Disease duration (years), median (IQR) 2.10 (1.10, 2.80)
Extent of disease
 Limited to left side of colon, n (%) 1 (4.8)
 Extensive, n (%) 20 (95.2)
Concomitant medications, at baseline
 Corticosteroids (oral), n (%) 12 (57.1)
 Aminosalicylates, n (%) 19 (90.5)
  5-aminosalicylates, n (%) 17 (81.0)
  Sulfasalazine, n (%) 3 (14.3)
 6-mercaptopurine/azathioprine, n (%) 9 (42.9)
Corticosteroid-refractory disease, n (%) 3 (14.3)
Corticosteroid-dependent disease, n (%) 16 (76.2)
CAI score, median (IQR) 9.0 (8.0, 11.0)
Partial Mayo score, median (IQR) 6.0 (5.0, 7.0)
Mayo score,a median (IQR) 7.0 (5.0, 8.5)
PUCAI score, median (IQR) 45.0 (40.0, 60.0)
CRP (mg/dL), median (IQR) 0.20 (0.00, 0.60)
TNF-α (pg/mL), median (IQR)b 1.020 (0.000, 1.640)
  1. an = 8
  2. bPlasma concentration of TNF-α was measured using a chemiluminescence enzyme immunoassay only at baseline because accurate measurement is not possible in the presence of IFX. A measured TNF-α plasma concentration under the detection limit (0.55 pg/mL) was defined as 0.00 pg/mL
  3. BMI Body mass index, CAI Clinical activity index, CRP C-reactive protein, IQR Interquartile range, PUCAI Pediatric ulcerative colitis activity index, TNF-α tumor necrosis factor-α.