Table 4.

Number of infusions required to resolve bleeding episodes

Treatment regimen
On demand
(n = 22)
Prophylactic
(n = 28)
No. of bleeding episodes 27 58 
Per bleeding episode, n (%)*   
 1 23 (85.2) 51 (87.9) 
 2 1 (3.7) 5 (8.6) 
 3 0 (0.0) 1 (1.7) 
 4 1 (3.7) 1 (1.7) 
 >4 2 (7.4) 0 (0.0) 
Infusions required to resolve bleeding episodes   
 Mean 3.2 1.2 
 SD 7.4 0.5 
 Median 1.0 1.0 
 IQR 1.0-1.0 1.0-1.0 
 Range 1-31 1-4 
Treatment regimen
On demand
(n = 22)
Prophylactic
(n = 28)
No. of bleeding episodes 27 58 
Per bleeding episode, n (%)*   
 1 23 (85.2) 51 (87.9) 
 2 1 (3.7) 5 (8.6) 
 3 0 (0.0) 1 (1.7) 
 4 1 (3.7) 1 (1.7) 
 >4 2 (7.4) 0 (0.0) 
Infusions required to resolve bleeding episodes   
 Mean 3.2 1.2 
 SD 7.4 0.5 
 Median 1.0 1.0 
 IQR 1.0-1.0 1.0-1.0 
 Range 1-31 1-4 

Investigators could treat patients with rFIXFc on demand at investigators’ discretion before initiating prophylaxis, in accordance with local standard of care. Therefore, patients may appear in >1 treatment regimen group. All infusions administered from initial sign of bleeding episode until last date/time within bleed window are counted.

SD, standard deviation.

*

Percentages are based on total number of bleeding episodes in each group.

One episode of spontaneous subdural hematoma in 1 patient; 1 episode of spontaneous spinal cord hematoma in 1 patient.

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