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. 2020 Nov 4;137(13):1818–1827. doi: 10.1182/blood.2020005673

Table 3.

ABRs (second 6-mo study period; FAS and PPAS)

FAS (N = 115) PPAS (N = 95)
FVIII trough level 1% to 3% (n = 57) FVIII trough level 8% to 12% (n = 53)* FVIII trough level 1% to 3% (n = 52) FVIII trough level 8% to 12% (n = 43)
Total ABR
 Mean (SD) 3.6 (7.5) 1.6 (3.4) 2.8 (3.0) 1.2 (2.4)
 Median (Q1 to Q3) 2.0 (0.0-4.0) 0.0 (0.0-2.0) 2.0 (0.0-4.0) 0.0 (0.0-2.0)
Spontaneous ABR
 Mean (SD) 2.5 (6.6) 0.7 (1.7) 1.7 (2.5) 0.6 (1.5)
 Median (Q1 to Q3) 0.0 (0.0-4.0) 0.0 (0.0-0.0) 0.0 (0.0-4.0) 0.0 (0.0-0.0)
Spontaneous joint ABR
 Mean (SD) 2.0 (6.4) 0.5 (1.7) 1.2 (2.0) 0.4 (1.4)
 Median (Q1 to Q3) 0.0 (0.0-2.0) 0.0 (0.0-0.0) 0.0 (0.0-2.0) 0.0 (0.0-0.0)
Joint ABR
 Mean (SD) 2.6 (7.4) 1.1 (2.6) 1.8 (2.2) 0.8 (2.3)
 Median (Q1 to Q3) 0.0 (0.0-2.0) 0.0 (0.0-0.0) 1.0 (0.0-3.0) 0.0 (0.0-0.0)
ABR of joints with ≥4 spontaneous bleeds in 6 consecutive months
 Mean (SD) 1.0 (6.8) 0.4 (1.5) 0.1 (0.6) 0.2 (1.3)
 Median (Q1 to Q3) 0.0 (0.0-0.0) 0.0 (0.0-0.0) 0.0 (0.0-0.0) 0.0 (0.0-0.0)
Injury-related ABR
 Mean (SD) 1.1 (2.0) 0.9 (2.6) 1.1 (1.9) 0.7 (1.7)
 Median (Q1 to Q3) 0.0 (0.0-2.0) 0.0 (0.0-0.0) 0.0 (0.0-2.0) 0.0 (0.0-0.0)
*

ABR based on 53 PwHA; data not available from 5 randomized PwHA who discontinued the study before the second 6-mo period.