For each cell, n = 200. The colors indicate the percent of virtual patients with simulated FX activity of ≥50%: green, at least 80%; orange, 70% to <80%; red, <70%. When the percent of virtual patients with simulated FX activity of ≥50% was <25%, the level of uncertainty ranged from 12% to 24%; when the percent of patients was ≥25%, uncertainty ranged from 1% to 10%. Non-Japanese assumes male sex, weight 80 kg, age 70 years; Japanese assumes male sex, weight 58 kg, age 80 years.

A total of 35 IU/kg was used for the mean baseline INR of the phase 3 studies (4.3 and 4.5), consistent with the dose used in the study protocols (and the indicated 4F-PCC dose for INR 4-6); 25 IU/kg was used for all other baseline INR levels.

Mean baseline INR of patients from the phase 3 studies included in the development of the model.