Table 5.
Low-grade stratum |
High-grade stratum |
Combined |
|||||||
---|---|---|---|---|---|---|---|---|---|
Variable | Cele (n = 30) | Plbo (n = 34) | P* | Cele (n = 19) | Plbo (n = 17) | P* | Cele (n = 49) | Plbo (n = 51) | P* |
Follow-up | |||||||||
Median time on study, y (range] |
2.1 (0.3–2.3) | 2.0 (0.0–2.4) | .75 | 1.4(0.2–2.3) | 1.3 (0.0–2.4) | .50 | 2.0 (0.2–2.3) | 2.0 (0.0–2.4) | .79 |
% scheduled† follow-up visits completed |
83 | 81 | .68 | 59 | 54 | .48 | 74 | 72 | .94 |
Treatment adherence | |||||||||
Median observed/expected pill counts‡ where drug was dispensed at previous visit, % |
88 | 90 | .68 | 85 | 86 | .48 | 88 | 89 | .45 |
% patients with treatment nterruption or early treatment termination |
33 | 38 | .68 | 42 | 59 | .32 | 37 | 45 | .40 |
No. of patients unmasked before end of study |
0 | 0 | NC | 0 | 1§ | .47 | 0 | 1§ | .51 |
Reasons for termination of treatment |
.75 | .68 | .76 | ||||||
No. of patients completed Study |
25 | 28 | 11 | 10 | 36 | 38 | |||
No. of patients with esophageal cancer |
0 | 0 | 3 | 3 | 3 | 3 | |||
No. of patients with esophagectomy due to persistent dysplasia |
0 | 0 | 2 | 0 | 2 | 0 | |||
No. of patients who died | 0 | 2 | 0 | 0 | 0 | 2 | |||
No. of patients with adverse event other than esophageal cancer or death |
3 | 3 | 2 | 1 | 5 | 4 | |||
No. of patients requesting early termination |
1 | 1 | 1 | 1 | 2 | 2 | |||
No. of patients with other reason∥ |
1 | 0 | 0 | 2 | 1 | 2 |
Cele = celecoxib; Plbo = placebo; NC = not calculable.
All statistical tests were two-sided Wilcoxon rank sum test for continuous variables and Fisher’s exact test for categorical variables.
Adjusted for deaths. Completion defined as submission of Concomitant Medication form, Histology Report form, or Follow-up Medical History form at a visit.
Note that 149 (24%) of the 619 visits in which drug was dispensed were missing data for return of study drug.
This patient was hospitalized with acute pancreatitis.
Includes use of protocol-denied photodynamic therapy, comorbidity-requiring surgery, or allergic reaction to Bactrim.