8.1.2. Safety Analysis The main analyses of DLTs will be based on the Per Protocol analysis set. Patients not meeting the cr iteria for inclusion in the Per Protocol Analysis set (i e,not evaluable for assessment of DLTs) will be replaced. Summaries and analyses of other safety parameters will include all patients in the Safety Analysis Set. Note only the safet y data before the start of any new anti -cancer sy stemic therapy will be included in safet y analysis. 8.1.2.1. Analysis of Primary Endpoint DLT is a primary endpoint of the study. The properties of the statistical methods for the analyses of DLTs are described in Section 4. Adverse events constituting DLTs are detailed in Section 3.2 of the study protocol. Adverse events and adverse events constituting DLTs will be listed per dose level (ie,by cohort) . A binary variable will be created at thepatient level to indicate whether or not a patient has experienced an y of the adverse events that are considered DLT. If required, a summary table will be created by cohort to present number and percentage of patients experiencing DLT and each specific adverse event constituting DLT. Adverse Events (AEs) will be graded by the investigator according to the CTCAE version 4.03 and code d using the Medical Dictionary for Regulatory Activities (MedDRA). The focus of AE summaries will be on Treatment Emergent Adverse Events, those with initial onset or increasing in severity after the first dose of study treatment and before the start of any new anti -cancer sy stemic therap y. The number and percentage of patients who experienced any AE, SAE, treatment related AE, and treatment related SAE will be summarized. The summaries will present AEs both on the entire study period by dose (i.e., by cohort) and by cycle . The number and percentage of patients who discontinued from study medications due to AE or discontinued from the study due to AE s will also be presented. AE, SAE, treatment related AE, treatment related SAE will be presented b y system organ class and preferred term for each cohort. Severity summary tables will also be presented where AE, SAE, treatment related AE, and treatment related SAE will be presented for each cohort by system organ class and preferred term according to the wor st toxicity grade. Treatment related AE in this study refers to those adverse events that are determined by investigator as related to either adenovirus, or plasmid DNA, or tremelimumab, or PF - 06801591. If deemed necessary , further summary of component -related AE may be presented.