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For the primary endpoint, the incidence of invasive breast cancer was reduced by 43% among women assigned to NOLVADEX 44 cases - NOLVADEX, 74 cases - placebo; p 0.004; relative risk RR ; 0.57, 95% CI: 0.39-0.84 ; . No data are available regarding the ER status of the invasive cancers. The stage distribution of the invasive cancers at diagnosis was similar to that reported annually in the SEER data base. Results are shown in Table 1. For each endpoint the following results are presented: the number of events and rate per 1, 000 women per year for the placebo and NOLVADEX groups; and the relative risk RR ; and its associated 95% confidence interval CI ; between NOLVADEX and placebo. Relative risks less than 1.0 indicate a benefit of NOLVADEX therapy. The limits of the confidence intervals can be used to assess the statistical significance of the benefits of NOLVADEX therapy. If the upper limit of the CI is less than 1.0, then a statistically significant benefit exists and pioglitazone.
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