Table 3.
Observed versus expected incidence of colorectal cancer and advanced precancerous lesions.
| Year 3 ITSa | ||
|---|---|---|
| (N = 591) | ||
| Colorectal cancer | Advanced precancerous lesions | |
| Number Observed | 1* | 63 |
| Assumed Incidence (based on pivotal study) (7) | 0.00686 | 0.076 |
| Expected Number | 4 | 45 |
| Observed Incidence | 0.0017 | 0.1066 |
| 95% CI two-sided | (0, 0.00797) | (0.0829, 0.1336) |
| P | 0.087 (one-sided) | 0.0091 (two-sided) |
aYear 3 ITS subjects had a negative baseline T0 mt-sDNA result, a valid year 3 mt-sDNA result, and an evaluable colonoscopy in year 3; Two-sided test used for advanced precancerous lesions because the incidence was higher than expected; One-sided 95% CI prespecified for colorectal cancer.
*Colorectal cancer was identified in month 22 of study and is not included in the year 3.