Table 2

Extent of exposure to pirfenidone

Integrated population (N=1299)
Duration of treatment, years
 Median (range)1.7 (>0 to 9.9)
  >0 to <1404 (31.1%)
  1 to <2350 (26.9%)
  2 to <3118 (9.1%)
  3 to <4102 (7.9%)
  ≥4325 (25.0%)
 Person exposure years (PEY)*3160
Daily dose, mg†
 Mean (SD)2053.8 (484.9)
 Median (range)2270.4 (25–3600)
  >0 to ≤1800295 (22.7%)
  >1800 to ≤2200228 (17.6%)
  >2200 to 2600736 (56.7%)
  >260019 (1.5%)
 Missing21 (1.6%)
  • *One PEY is the equivalent of one patient exposed to study drug for 1 year; total PEY is the sum of the PEY of each patient.

  • †Calculated over the total duration of use, excluding the 2-week titration period.