Table 5

Dosing and consumption of rVIII-SingleChain, AsBR, ABR, and location of bleeds with rVIII-SingleChain in on-demand therapy and prophylaxis

On-demand (N = 27)Prophylaxis
All (N = 146)Three times per week (N = 79)Twice per week (N = 47)
Dose, IU/kg     
 Median (Q1, Q3) 30 (25, 40) 31 (27, 40) 30 (26, 38) 35 (30, 41) 
Consumption, IU/kg per year     
 Median  4283 4514 3669 
 Mean (SD)  4494 (1778.17) 4769 (1237.42) 3974 (2396.93) 
AsBR     
 Median (Q1, Q3) 11.73 (2.8, 36.5) 0.0 (0.0, 2.4) 0.0 (0.0, 3.6) 0.0 (0.0, 1.1) 
 Mean (SD) 24.84 (33.84) 2.10 (4.76) 2.33 (3.87) 2.33 (6.67) 
 N bleeds per year* (95% CI) 19.5 (17.8-21.3) 1.6 (1.3-1.8) 1.9 (1.6-2.3) 1.3 (1.0-1.8) 
ABR     
 Median (Q1, Q3) 19.64 (6.2, 46.5) 1.14 (0.0, 4.2) 1.93 (0.0, 4.9) 0.0 (0.0, 3.3) 
 Mean (SD) 31.14 (35.56) 3.11 (5.05) 3.34 (4.26) 3.27 (6.83) 
 N bleeds per year (95% CI) 24.9 (23.0-27.0) 2.6 (2.3-2.9) 2.9 (2.5-3.4) 2.4 (1.9-3.0) 
Location of spontaneous bleeds, N (%)     
 Joint 419 (91.1) 147 (94.2) 104 (97.2) 39 (95.1) 
 Muscle 55 (12.0) 11 (7.1) 7 (6.5) 3 (7.3) 
 Other 57 (12.4) 12 (7.7) 8 (7.5) 1 (2.4) 
On-demand (N = 27)Prophylaxis
All (N = 146)Three times per week (N = 79)Twice per week (N = 47)
Dose, IU/kg     
 Median (Q1, Q3) 30 (25, 40) 31 (27, 40) 30 (26, 38) 35 (30, 41) 
Consumption, IU/kg per year     
 Median  4283 4514 3669 
 Mean (SD)  4494 (1778.17) 4769 (1237.42) 3974 (2396.93) 
AsBR     
 Median (Q1, Q3) 11.73 (2.8, 36.5) 0.0 (0.0, 2.4) 0.0 (0.0, 3.6) 0.0 (0.0, 1.1) 
 Mean (SD) 24.84 (33.84) 2.10 (4.76) 2.33 (3.87) 2.33 (6.67) 
 N bleeds per year* (95% CI) 19.5 (17.8-21.3) 1.6 (1.3-1.8) 1.9 (1.6-2.3) 1.3 (1.0-1.8) 
ABR     
 Median (Q1, Q3) 19.64 (6.2, 46.5) 1.14 (0.0, 4.2) 1.93 (0.0, 4.9) 0.0 (0.0, 3.3) 
 Mean (SD) 31.14 (35.56) 3.11 (5.05) 3.34 (4.26) 3.27 (6.83) 
 N bleeds per year (95% CI) 24.9 (23.0-27.0) 2.6 (2.3-2.9) 2.9 (2.5-3.4) 2.4 (1.9-3.0) 
Location of spontaneous bleeds, N (%)     
 Joint 419 (91.1) 147 (94.2) 104 (97.2) 39 (95.1) 
 Muscle 55 (12.0) 11 (7.1) 7 (6.5) 3 (7.3) 
 Other 57 (12.4) 12 (7.7) 8 (7.5) 1 (2.4) 

Q1, lower quartile; Q3, upper quartile.

*

Estimated number of spontaneous bleeds per subject per year based on a Poisson distribution.

Estimated number of bleeds per subject per year based on a Poisson distribution.

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