Table 5.

Follow-up, adherence, and treatment termination ^*

	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.