Table 2.
Dataset | No. of patients | No. of FIX activity records | Age (years) [median (range)] | Body weight (kg) [median (range)] |
---|---|---|---|---|
Modelling dataset |
12 (phase 1/2a) 123 (phase 3) |
1,400 | 31.3 (12.1–76.8) | 73.3 (45.0–186.7) |
Validation dataset | 100 (phase 3)a | 1,027 | 30.7 (12.1–71.6) | 72.5 (45.2–186.7) |
FIX factor IX
aPhase 1/2a was a single-dose study; no peaks/troughs were collected