Table 1 Patient disposition by treatment group.
Placebo (n (%)) | Exisulind 200 mg (n (%)) | Exisulind 400 mg (n (%)) | Total | |
---|---|---|---|---|
Total No of patients enrolled | 95 | 91 | 95 | 281 |
Hyperplastic polyps* | 41 | 43 | 42 | 126 |
ITT population (adenomatous polyps only) | 54 | 48 | 53 | 155 |
Discontinued prematurely† | 11 (20.4) | 10 (20.8) | 20 (37.7) | 41 |
Efficacy evaluable population | 43 (79.6) | 38 (79.2) | 33 (62.3) | 114 |
*Patients with histologically confirmed hyperplastic polyps were excluded from the per study protocol.
†Reasons for discontinuation included adverse events, consent withdrawal, protocol violation, and other (among 155 patients with adenoma).
ITT, intention to treat.