Table 1.

Criteria for inclusion in the PPAS of the pivotal study

Regimen	Treatment	Criterion	n (%)
Prophylaxis (N = 120)	Prophylaxis	Infusion interval of 5 or more days did not occur more than 3 times	107 (89.2)
		The daily dose was below 35 IU/kg in no more than 10% of the infusions	116 (96.7)
		The daily dose was above 55 IU/kg in no more than 10% of the infusions	118 (98.3)
		No dose adjustments resulting from bleeding episodes	118 (98.3)
		All of above	101 (85.8)
	Breakthrough bleeding episode	Dose to treat the bleed was below 5 IU/kg for minor bleed, below 10 IU/kg for moderate bleed, or below 25 IU/kg for a major bleed for no more than 5 bleeds (minor/moderate/major taken together)	120 (100.0)
On-demand (N = 17)	Bleeding episode	Dose to treat the bleed was below 5 IU/kg for minor bleed, below 10 IU/kg for moderate bleed, or below 25 IU/kg for a major bleed for no more than 5 bleeds (minor/moderate/major taken together)	17 (100.0)

One hundred twenty-one subjects were assigned to the prophylaxis regimen (full analysis set); however, there were only 120 subjects (safety analysis set) who received prophylactic treatment with BAX 855, of whom 101 qualified for the PPAS. One subject received Advate for PK and then discontinued the study. For guidelines for treatment of bleeds and definition of minor, moderate, or major bleed, refer to the supplemental Data.

N, subjects who received treatment; n, subjects who met criterion for inclusion in the PPAS.