• PFS and OS not c ensoring event s that occur after the cutoff .. • OS with c ompeting events being taken into consideration. Competing events for death are “definite” lost to follow -up and withdrawal of consent for continued survival assessments. Both of these competing events are subject to revision for an individual subject with the passage of time. The cumulative incidence estimates will be plotted if the percent of subjects with competing events in either arm exceeds 3%. • PFS with competing events being taken into consideration. Competing events for PFS event are lost to follow -up, withdrawal of consent , start of other anti -cancer therapy , or two or more missing scans prior to a PFS event . The cumulative incidence estimates will be plotted if the percent of subjects with competing events in either arm exceeds 3%. 8.2.2.3 Other Analyse s of Primary Endpoints (PFS/OS) • Strata homogeneity will be assessed by including arm by stratum interaction with main effect terms in the Cox proportional hazard model. If the 2 -sided p value for this test of 05FPRF Immune Design Corp. I MDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 30 / 36 homogeneity is significant at two -sided 0.10, then the stratum -specific hazard ratio estimates and confidence intervals will be computed. If the statistical criterion is not met then the test of homogeneity will be regarded as an exploratory analysis of the data collected. Thus, the outcome of the strata homogeneity test will not affect the interpretation of significance for the primary test, but will affect the way the results are presented or subsequently analyzed. • Clinical site homogeneity will be assessed by including in the model site grouping multi - level main effect terms and also interaction terms for arm by categorical site grouping . • Effect modifier analyses will be performed for putatively prognostic factors, including those explored previously in the literature as well as those hypothesized to be predictive in the context of this study. Effect modification will be assessed one factor at a time in stratified models. Each factor will be analyzed as eith er a natural dichotomy, a dichotomized ordered categorical with cut point chosen based on biologic considerations, or a continuous variable dichotomized at the overall median. A separate effect size estimate for arm and its 95% confidence interval will be computed for each level of the dichotomy using SAS . The four Kaplan -Meier estimates (arm by factor) for each of the factors analyzed as effect modifiers will be plotted on one graph. • Cox proportional hazard models with multiple added prognostic covariates will be estimated. The covariates to be added will include those explored previously in the literature as well as those hypothesized to be predictive in the context of this study . Variable selection method such as stepwise method will be used to build the multivariate Cox proportional hazard model . .