Table 3

Treatment-emergent adverse events*

Phase 3 multinational trials‡
Integrated population (N=1299)†Pirfenidone (N=623)Placebo (N=624)
Duration of exposure, median (range), years1.7 (>0, 9.9)1.0 (>0, 2.3)1.0 (>0, 2.3)
Treatment-emergent adverse event, %
 Upper respiratory tract infection30.626.825.3
 Idiopathic pulmonary fibrosis29.313.019.9
 Weight decreased15.610.15.4
 Back pain15.410.410.4
  • *Occurring in ≥15% of patients in the cumulative clinical database.

  • †Includes two patients in study 002 with a diagnosis of “pulmonary fibrosis.”

  • ‡CAPACITY (studies 004 and 006) and ASCEND (study 016).