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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