Table 6.

Reasons for subject noncompletion

ReasonPlacebo (n = 26)Pirfenidone at 1200 mg/d (n = 26)Pirfenidone at 2400 mg/d (n = 25)P
Dialysis4 (15%)0 (0%)1 (4%)0.07
Gastrointestinal symptoms1 (4%)2 (8%)6 (24%)0.06
Rash01 (4%)1 (4%)0.59
Heart failure01 (4%)00.37
Aortic dilation01 (4%)00.37
Bradycardia1 (4%)000.37
Urinary tract infection001 (4%)0.35
Fatigue02 (8%)2 (8%)0.34
Cancer001 (4%)0.35
Noncompliance02 (8%)3 (12%)0.21
Lost to follow-up01 (4%)00.37
Other (patient moved)01 (4%)00.37
  • Shown are the number of subjects randomized to each treatment group who discontinued treatment before the end of the study and the reasons for discontinuation. Several subjects had more than one adverse event that contributed to their withdrawal from the study. One patient withdrew from study for personal reasons (moved out of state) before the first post-treatment visit. The P value was calculated using Pearson's χ2 test.