Table 3.

Change in protein C level from study Day 1 to study Day 7 in the primary efficacy population

	Alternative therapy	Standard therapy	P-value*	Absolute difference in change	Two-sided 95% CI
Primary Objective:	n = 202	n = 221
Change in PC, days 1 to 7†, mean activity units (%) ± SD	31 ± 29	24 ± 29	0.011	7	(2, 13)
Classification of change‡, n (%)
No change or decreased	38 (18.8)	61 (27.6)
Increased, but still deficient	64 (31.7)	60 (27.1)
Increased and above LLN	100 (49.5)	100 (45.2)
Secondary Objective Moderate deficiency group:	n = 171	n = 175
Change in PC, days 1 to 7†, mean activity units (%) ± SD,	30 ± 29	24 ± 28	0.047	6	(0, 12)
Classification of change‡, n (%)
No change or decreased	35 (20.5)	46 (26.3)
Increased, but still deficient	50 (29.2)	44 (25.1)
Increased and above LLN	86 (50.3)	85 (48.6)
Secondary Objective Severe deficiency group:	n = 31	n = 46
Change in PC, days 1 to 7†, mean activity units (%) ± SD,	38 ± 27	25 ± 32	0.063	13	(-1, 27)
Classification of change‡, n (%)
No change or decreased	3 (9.7)	15 (32.6)
Increased, but still deficient	14 (45.2)	16 (34.8)
Increased and above LLN	14 (45.2)	15 (32.6)

*P-value calculated by an unadjusted two-sample t-test.

^†Change in protein C results analyzed with imputation.

^‡Percentage of protein C change from baseline >10%. The P-value for protein C classification as increased in the primary objective is 0.03, calculated by a Chi-Square test.

CI, confidence interval; LLN, lower limit of normal; PC, protein C