Table 4.
Modulation of Metaplasia Index (MI) from Baseline to 3 Months by Treatment Arm at Each Dose Level, by Smoking Status#
Smoking status | Treatment | Variable | N | Mean | Std Dev | Minimum | Median | Maximum |
---|---|---|---|---|---|---|---|---|
FORMER | CCX, Dose 0 | MI0 | 8 | 6.25 | 8.63 | 0.00 | 0.00 | 16.67 |
MI3 | 8 | 6.25 | 12.40 | 0.00 | 0.00 | 33.33 | ||
MI30 | 8 | 0.00 | 12.60 | −16.67 | 0.00 | 16.67 | ||
CCX, Dose +1 | MI0 | 7 | 4.76 | 8.13 | 0.00 | 0.00 | 16.67 | |
MI3 | 7 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | ||
MI30 | 7 | −4.76 | 8.13 | −16.67 | 0.00 | 0.00 | ||
Placebo | MI0 | 13 | 5.13 | 10.51 | 0.00 | 0.00 | 33.33 | |
MI3 | 13 | 1.28 | 4.62 | 0.00 | 0.00 | 16.67 | ||
MI30 | 13 | −3.85 | 12.08 | −33.33 | 0.00 | 16.67 | ||
CURRENT | CCX, Dose 0 | MI0 | 25 | 15.00 | 21.97 | 0.00 | 0.00 | 66.67 |
MI3 | 25 | 16.13 | 18.95 | 0.00 | 16.67 | 66.67 | ||
MI30 | 25 | 1.13 | 14.87 | −33.33 | 0.00 | 33.33 | ||
CCX, Dose +1 | MI0 | 29 | 12.87 | 14.93 | 0.00 | 16.67 | 50.00 | |
MI3 | 29 | 15.92 | 17.88 | 0.00 | 16.67 | 66.67 | ||
MI30 | 29 | 3.05 | 18.44 | −33.33 | 0.00 | 33.33 | ||
Placebo | MI0 | 44 | 15.45 | 23.18 | 0.00 | 0.00 | 83.33 | |
MI3 | 44 | 16.06 | 22.45 | 0.00 | 8.33 | 100.00 | ||
MI30 | 44 | 0.61 | 22.43 | −50.00 | 0.00 | 66.67 |
CCX, Dose 0; low-dose celecoxib
CCX, Dose +1; high-dose celecoxib
MI0; metaplasia index baseline
MI3; metaplasia index at 3 months
MI30; metaplasia index difference (MI3 – MI0)
one patient did not have a 3-month metaplasia index reading from the biopsy