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Table 2 Demographics and baseline data

From: Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study

  12–18 years 6–12 years 2–6 years 0.5–2 years Total (N = 59)
Tablet 10 mg eq. (n = 4) Tablet 20 mg eq. (n = 5) Tablet 10 mg eq. (n = 4) Suspension 10 mg eq. (n = 11) Tablet 20 mg eq. (n = 4) Suspension 20 mg eq. (n = 5) Suspension 10 mg eq. (n = 11) Suspension 20 mg eq. (n = 5) Suspension 10 mg eq. (n = 6) Suspension 20 mg eq. (n = 4)
Sex Male 3 (75) 1 (20) 3 (75) 5 (45) 2 (50) 5 (100) 6 (55) 2 (40) 3 (50) 3 (75) 33 (56)
Female 1 (25) 4 (80) 1 (25) 6 (55) 2 (50)   5 (45) 3 (60) 3 (50) 1 (25) 26 (44)
Race White 4 (100) 4 (80) 2 (50) 7 (64) 3 (75) 5 (100) 7 (64) 3 (60) 5 (83) 4 (100) 44 (75)
Black 1 (20) 1 (2)
Asian   1 (9) 1 (9) 1 (20) 3 (5)
Hispanic 1 (20) 2 (50) 1 (9) 1 (25) 2 (18) 7 (12)
Missing 2 (18) 1 (9) 1 (17) 4 (7)
Age (years) Mean ± SD 16.0 ± 1.4 14.8 ± 1.9 10.0 ± 0.8 7.5 ± 1.5 8.5 ± 1.9 9.2 ± 1.8 3.4 ± 1.2 3.6 ± 1.5 0.5 ± 0.5 0.5 ± 0.6 6.8 ± 4.9
Median 16.5 15.0 10.0 7.0 9.0 9.0 3.0 4.0 0.5 0.5 6.0
Range 14.0–17.0 12.0–17.0 9.0–11.0 6.0–11.0 6.0–10.0 7–11.0 2.0–5.0 2.0–5.0 0.5–1.0 0.5–1.0 0.5–17.0
Weight (kg) Mean ± SD 68.6 ± 8.0 56.9 ± 8.9 40.2 ± 6.7 29.8 ± 4.9 37.3 ± 12.2 35.0 ± 7.9 17.8 ± 6.5 16.0 ± 3.3 8.9 ± 1.7 9.6 ± 2.2 29.5 ± 18.3
Median 67.5 58.0 41.6 28.2 34.9 32.0 15.3 16.0 9.4 9.8 27.7
Range 61.5–77.8 42.2–64.4 31.5–46.1 24.0–38.2 27.0–52.5 28.5–47.8 11.0–29.1 11.0–20.0 6.2–11.0 6.7–11.9 6.2–77.8
Height (cm) Mean ± SD 173.7 ± 9.0 165.9 ± 11.9 141.6 ± 6.0 125.3 ± 8.7 133.1 ± 14.8 139.5 ± 9.8 92.5 ± 21.6 99.1 ± 11.3 72.0 ± 7.6 75.7 ± 6.3 117.7 ± 34.0
Median 170.0 167.4 141.7 125.0 132.6 136.0 98.0 103.0 73.5 75.8 118.0
Range 167.6–187.0 149.5–180.1 136.0–147.0 114.3–143.5 116.0–151.0 132.0–156.7 35.0–118.0 83.5–111.0 59.0–80.0 68.0–83.0 35.0–187.0
BMI (kg/m2) Mean ± SD 22.8 ± 2.6 20.6 ± 1.7 20.1 ± 3.4 19.0 ± 2.1 20.8 ± 4.8 17.8 ± 2.1 16.9 ± 3.2 16.1 ± 1.1 17.1 ± 1.0 16.5 ± 1.4 18.5 ± 3.0
Median 21.8 19.9 19.6 18.4 19.2 16.9 15.8 15.8 17.2 16.9 17.8
Range 20.8–26.6 18.9–22.7 16.8–24.2 15.9–23.0 17.0–27.9 15.4–20.6 14.6–25.7 15.1–18.0 15.6–18.3 14.5–17.4 14.5–27.9
  1. Data are n (%) unless stated otherwise
  2. BMI body mass index; eq., equivalent, SD standard deviation