Table 2.

Summary of exposure to rFIX



rFIX infusion type*

On-demand treatment
Prophylaxis
Surgery related§
Total
No. of patients  54   42   23   56  
Total rFIX administered, IU/patient     
    Cumulative   1 742 860   3 791 388   206 941   5 741 189  
    Median (range)   20 515 (690-240 293)   83 825 (530-411 780)   6130 (2000-31 580)   91 620 (1260-483 140)  
Dose/infusion, IU/kg     
    Median (range)   62.70 (8.20-292.00)   60.60 (9.70-230.40)   70.00 (29.30-260.00)   61.40 (8.20-292.00)  
    Mean ± SD   75.58 ± 42.47   71.57 ± 36.89   89.87 ± 51.95   73.49 ± 39.47  
No. of infusions     
    Cumulative   1505   3320   207   5032  
    Median (range)   19.00 (1-108)   71.50 (1-212)   6.00 (1-40)   100.00 (1-239)  
    Mean ± SD   27.87 ± 27.76   79.05 ± 68.74   9.00 ± 8.55   89.86 ± 74.04  
Duration of exposure, d     
    Cumulative   1443   3311   117   4858  
    Median (range)   19.00 (1-107)   71.50 (1-212)   4.00 (1-20)   93.50 (1-225)  
    Mean ± SD
 
26.72 ± 26.41
 
78.83 ± 68.46
 
5.09 ± 3.96
 
86.75 ± 71.73
 


rFIX infusion type*

On-demand treatment
Prophylaxis
Surgery related§
Total
No. of patients  54   42   23   56  
Total rFIX administered, IU/patient     
    Cumulative   1 742 860   3 791 388   206 941   5 741 189  
    Median (range)   20 515 (690-240 293)   83 825 (530-411 780)   6130 (2000-31 580)   91 620 (1260-483 140)  
Dose/infusion, IU/kg     
    Median (range)   62.70 (8.20-292.00)   60.60 (9.70-230.40)   70.00 (29.30-260.00)   61.40 (8.20-292.00)  
    Mean ± SD   75.58 ± 42.47   71.57 ± 36.89   89.87 ± 51.95   73.49 ± 39.47  
No. of infusions     
    Cumulative   1505   3320   207   5032  
    Median (range)   19.00 (1-108)   71.50 (1-212)   6.00 (1-40)   100.00 (1-239)  
    Mean ± SD   27.87 ± 27.76   79.05 ± 68.74   9.00 ± 8.55   89.86 ± 74.04  
Duration of exposure, d     
    Cumulative   1443   3311   117   4858  
    Median (range)   19.00 (1-107)   71.50 (1-212)   4.00 (1-20)   93.50 (1-225)  
    Mean ± SD
 
26.72 ± 26.41
 
78.83 ± 68.46
 
5.09 ± 3.96
 
86.75 ± 71.73
 
*

Excludes data for 5 patients due to inadequate source documentation at 3 study sites.

Excludes data for 2 patients from start of inhibitor development.

Includes primary and secondary (routine and intermittent) prophylaxis.

§

Excludes continuous infusions.

A patient may have received doses more than once a day for different reasons.

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