Table 5.

Incidence of adverse events and compliance

 TotalPlaceboSulindacEtodolac
n = 179n = 58n = 60n = 61
Adverse events
 Abdominal pain5 (3.0%)2 (3.4%)2 (3.3%)1 (1.6%)
 Heartburn2 (1.1%)1 (1.7%)0 (0%)1 (1.6%)
 Diarrhea2 (1.1%)1 (1.7%)1 (1.7%)0 (0%)
  Exanthema1 (0.6%)0 (0%)1 (1.7%)0 (0%)
 Chest discomfort1 (0.6%)0 (0%)0 (0%)0 (0%)
 Liver dysfunctiona 2 (1.1%)1 (1.7%)0 (0%)1 (1.6%)
 Renal dysfunctionb 2 (1.1%)0 (0%)1 (1.7%)1 (1.6%)
Average compliance92.7%93.9%91.7%92.5%
  • aLiver dysfunction was defined as ALT level greater than the upper limit of normal.

  • bRenal dysfunction was defined as creatinine level greater than the upper limit of normal.