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Re: walldiver post# 2090

Thursday, 02/15/2007 6:43:33 PM

Thursday, February 15, 2007 6:43:33 PM

Post# of 12660
9901 Cox model was described in the JCO 9901 publication - I think if this is the model adopted without knowledge of 9902a dataset, then whether it was prospectively specified for 9901 or not, we should be fine, because the 9902a result validated the model.

"To test the robustness of the survival findings, the individual effect of 20 potentially important prognostic factors that have been described in the literature was evaluated. Using exploratory Cox regression models, each one having treatment and a single covariate as main effects, the treatment effect remained significant. Covariates that were significant at the .05 level were then selected to build a predictive multicovariate Cox regression survival model. A backwards stepwise selection method (P = .05 for entry and P = .10 for removal, likelihood ratio test) was used to identify significant prognostic factors and their impact on treatment effect."

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