Table 2

Duration of treatment exposure

Placebo twice daily200 mg celecoxib twice daily 400 mg celecoxib twice daily
Efficacy Population*
All randomized in both APC core and extension study (% out of total randomized)679 (33.4)685 (33.7)671 (32.9)
Subjects (% of arm randomized) whose duration of treatment lasted:
 0-2 y203 (29.9)199 (29.0)197 (29.4)
 >2-3 y220 (32.4)220 (32.1)176 (26.2)
 >3-4 y246 (36.2)243 (35.5)282 (42.0)
 >4 y10 (1.5)23 (3.4)16 (2.4)
Median y (range)2.95 (0.002-4.22)2.94 (0.01-4.34)2.99 (0.02-0.439)
APC trial extension study participants with year 5 colonoscopy results (%)214 (31.5)207 (30.0)218 (32.5)
APC trial extension study participants with year 5 colonoscopy results (%)214 (31.5)207 (30.0)218 (32.5)
Subjects (% with Year 5 colonoscopy results) whose duration of treatment lasted:
 0-2 y7 (3.3)8 (3.9)8 (3.7)
 >2-3 y74 (34.6)64 (30.9)60 (27.5)
 >3-4 y125 (58.4)121 (58.5)138 (63.3)
 >4 y8 (3.7)14 (6.8)12 (5.5)
Median (range) y3.02 (0.76-4.22)3.05 (0.14-4.33)3.07 (0.02-4.38)
Safety population
All participants treated in both APC core and extension study (% out of total participants treated)676 (33.3)683 (33.7)669 (33.0)
Subjects (%) whose duration of treatment lasted:
 0-2 y200 (29.6)197 (28.8)195 (29.1)
 >2-3 y220 (32.5)220 (32.2)176 (26.3)
 >3-4 y246 (36.4)243 (35.6)282 (42.2)
 >4 y10 (1.5)23 (3.4)16 (2.4)
Median (range) y2.95 (0.002-4.22)2.94 (0.01-4.34)2.99 (0.02-0.439)
  • *Efficacy was determined by comparing the cumulative incidence of adenoma detection over 5 y of surveillance.

  • Safety analyses included all investigator-reported events occurring in the interval from first study drug use to 30 d after last study drug use.