TABLE 2.

Plasma‐derived factor X concentrate usage for routine prophylaxis in studies TEN02 and TEN05

	Study TEN02 <12 years of age (n  =  9)	Study TEN05 1–32 years of age (n =  8)
Dosing
Dose per infusion, IU/kg
Mean (SD)	38.8 (9.0)	32.5 (11.8)
Median (range)	39.6 (18.0–47.3)	27.9 (21.9–53.6)
Infusions, n
Mean (SD)	59.7 (5.1)	154.9 (150.6)
Median (range)	61 (47–65)	98.5 (39–492)
Infusions per month, n
Mean (SD)	9.3 (1.0)	5.6 (3.2)
Median (range)	9.65 (7.3–10.6)	5.4 (1.4–10.1)
Dose per month, IU/kg
Mean (SD)	358.0 (79.8)	206.2 (190.4)
Median (range)	389.3 (173.2–426.4)	135.5 (37.5–540.2)
Dose per year, IU/kg
Mean (SD)	NA	2490.3 (2299.1)
Median (range)	NA	1635.6 (453.1–6522.3)
Efficacy and reported bleeds
Efficacy rated as excellent, %	100	100
Bleeds reported on prophylaxis
Total number	10	17
Location	Five nosebleeds Four instances of menorrhagia One minor bleed from a cut/injury	Six joint Two mucosal Two muscle Seven other (three subcutaneous, one soft tissue, three vaginal)
Number of severe bleeds on prophylaxis	3	3

Data are from TEN02 ¹² , ¹⁸ and TEN05. ¹³ , ^{18 .}

Abbreviations: NA, not applicable; SD, standard deviation.