Table 1

Patients and FVIII data

ChildrenAdolescent/adult
Study Pediatric11  Pivotal and continuation20  
Median age, y (range) 3.5 (1.1-6.0) 19 (10-66) 
Median weight, kg (range) 16 (11-27) 68 (35-108) 
No. of subjects 52 100 
No. of PK assessments 52 184 
No. of FVIII activity data 206 1829 
Blood sampling schedule Reduced schedule Full schedule 
    Preinfusion sample Within 30 minutes Immediately before 
    Postinfusion samples 1, 9, 24, and 48 hours 15 and 30 minutes, 1, 3, 6, 9, 24, 28, 32, and 48 hours 
ChildrenAdolescent/adult
Study Pediatric11  Pivotal and continuation20  
Median age, y (range) 3.5 (1.1-6.0) 19 (10-66) 
Median weight, kg (range) 16 (11-27) 68 (35-108) 
No. of subjects 52 100 
No. of PK assessments 52 184 
No. of FVIII activity data 206 1829 
Blood sampling schedule Reduced schedule Full schedule 
    Preinfusion sample Within 30 minutes Immediately before 
    Postinfusion samples 1, 9, 24, and 48 hours 15 and 30 minutes, 1, 3, 6, 9, 24, 28, 32, and 48 hours 
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