Table 4

Incidence of adverse events after randomization

Adverse event*Placebo twice daily200 mg celecoxib twice daily400 mg celecoxib twice daily
All serious adverse events—subjects experiencing event (%)116 (17.2)125 (18.3)142 (21.2)
 RR (95% CI)1.1 (0.8,1.3)1.2 (1.0,1.5)
 Deaths7 (1.04)9 (1.32)13 (1.94)
 RR (95% CI)1.3 (0.5-3.4)1.9 (0.8-4.7)
Any adverse event—subjects with AE/subjects in cohort (%)608/676 (89.9)641/683 (93.9)629/669 (94.0)
 RR (95% CI)1.0 (1.0-1.1)1.0 (1.0-1.1)
 Renal/hypertensive disorders119/676 (17.6)149/683 (21.8)122/669 (18.2)
 RR (95% CI)1.2 (1.0-1.5)1.0 (0.8-1.3)
 Gastrointestinal ulceration and hemorrhage70/676 (10.4)73/683 (10.7)63/669 (9.4)
 RR (95% CI)1.0 (0.8-1.4)0.9 (0.7-1.3)
 Cardiovascular and thromboembolic disorders§26/676 (3.8)41/683 (6.0)50/669 (7.5)
 RR (95% CI)1.6 (1.0-2.5)1.9 (1.2-3.1)
Aspirin users—any adverse event—subjects with AE/subjects using aspirin (%)201/219 (91.8)193/205 (94.1)198/211 (93.8)
 RR (95% CI)1.0 (1.0-1.1)1.0 (1.0-1.1)
 Renal/hypertensive disorders39/219 (17.8)54/205 (26.3)33/211 (15.6)
 RR (95% CI)1.5 (1.0-2.1)0.9 (0.6-1.3)
 Gastrointestinal ulceration and hemorrhage20/219 (9.1)27/205 (13.2)26/211 (12.3)
 RR (95% CI)1.4 (0.8-2.5)1.3 (0.8-2.3)
 Cardiovascular and thromboembolic disorders15/219 (6.8)20/205 (9.8)18/211 (8.5)
 RR (95% CI)1.4 (0.7-2.7)1.2 (0.6-2.4)
Nonaspirin users—any adverse event—subjects with AE/subjects not using aspirin (%)409/457 (89.5)450/478 (94.1)436/458 (95.2)
 RR (95% CI)1.0 (1.0-1.1)1.1 (1.0-1.1)
 Renal/hypertensive disorders80/457 (17.5)95/478 (19.9)89/458 (19.4)
 RR (95% CI)1.1 (0.9-1.5)1.1 (0.8-1.5)
 Gastrointestinal ulceration and hemorrhage50/457 (10.9)46/478 (9.6)37/458 (8.1)
 RR (95% CI)0.9 (0.6-1.3)0.7 (0.5-1.1)
 Cardiovascular and thromboembolic disorders11/457 (2.4)21/478 (4.4)32/458 (7.0)
 RR (95% CI)1.8 (0.9-3.7)2.9 (1.5-5.7)
  • *Treatment-emergent adverse events included were those that occurred during the time after the first dose of study mediation to 30 d after the last dose of study medication.

  • Category includes reports of elevated creatinine, fluid retention/edema, hypertension, proteinuria, and renal failure.

  • Category includes anemia, gastrointestinal bleeding, gastritis/duodenitis, upper or lower gastrointestinal ulceration, and other hemorrhage.

  • §Category includes angina, myocardial infarction, cardiovascular therapeutic procedure, cerebrovascular disease, peripheral vascular disease, peripheral vascular therapeutic procedure, venous thrombosis or thromboembolism, and death or circulatory collapse due to cardiovascular causes.