Table 3.

ABRs

Characteristics	10 IU/kg	40 IU/kg	On demand
All patients
N	30	29	15
Median (IQR)	2.93 (0.99-6.02)	1.04 (0.00-4.00)	15.58 (9.56-26.47)
Estimated rate (95% CI)*	4.56 (3.01-6.90)	2.51 (1.42-4.43)	—
P value†	.40	.01
Previous prophylaxis patients
N	20	17	2
Bleeding rate during the last 12 months before trial‡
Median	4.75	4.00	9.50
Estimated rate	5.13	7.49	9.50
Bleeding rates during trial
Median	2.99	1.93	25.69
Estimated rate	4.68	3.33	29.4
Previous on-demand patients
N	10	12	13
Bleeding rate during the last 12 months before trial‡
Median	14.0	12.5	15.0
Estimated rate	17.9	21.2	22.7
Bleeding rates during trial
Median	2.06	0.52	13.0
Estimated rate	4.30	1.32	17.6
All patients by type of bleed
Spontaneous bleeding episodes
Median (IQR)	0.97 (0.00-4.01)	0.00 (0.00-0.98)	11.1 (7.16-15.8)
Estimated rate (95% CI)*	3.14 (1.78-5.56)	1.22 (0.48-3.10)
Traumatic bleeding episodes
Median (IQR)	0.98 (0.00-1.93)	0.00 (0.00-2.04)	1.73 (0.00-8.95)
Estimated rate (95% CI)*	1.35 (0.81-2.24)	1.29 (0.76-2.19)

^*Estimated rates for prophylaxis patients are based on a Poisson regression model with dose as a factor, allowing for overdispersion and using treatment duration as an offset.

^†P values are from the 1-sided test of the null hypothesis that the estimated rate is at least 4.8, evaluated at the 2.5% level.

^‡Bleeding rate during the last 12 months before trial on that particular treatment regimen.