In addition, a relationship between an induced anti -NY-ESO -1 immune response as well as tumor tissue changes during study treatment and c linical outcomes will be evaluated using peripheral blood and tumor tissue biopsies collected during study treatment at select sites. 8.3 Safety Analyses All analyses for the safety evaluation variables will be performed on safety set by treatment arm and overall . Baseline is defined as the last non- missing value prior to the first dose date on day 1, unless otherwise noted. 8.3.1 Adverse Events The verbatim terms used in the e CRF by investigators to identify adverse events will be coded to a system organ class (SOC) and a preferred term (PT) using the current Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 or higher . The severity of adverse events is assessed in National Cancer Institute (NCI) common toxicity criteria for adverse events (CTCAE) Version 4.03 or higher . Only TEAEs occurring from the time of the first dose through 30 days after the last dose of the study drug and medical events of interest, immune -mediated events and related AEs will be summarized , while all AEs captured in eCRF will be listed in data listings . 05FPRF Immune Design Corp. I MDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 33 / 36 TEAE will be summarized by system SOC and PT, by severity, by relationship to study treatment , and by action taken. Tables will be sorted by frequency in incidence (the highest to lowest inc idence in total column ). The following TEAEs will be tabulated and organized as follows:  Overall Summary of Treatment Emergent Adverse Events  TEAEs by system organ class and preferred term  TEAEs by system organ class , preferred term and worst NCI CTCAE grade  Severe TEAEs (Grade 3 or higher) by system organ class and preferred term  SAEs by system organ class and preferred term and w orst NCI CTCAE grade  Related TEAEs by system organ class and preferred term  Related SAEs by system organ class and preferred term  Related TEAEs by system organ class , preferred term and w orst NCI CTCAE grade  Related SAEs by system organ class and preferred term and worst NCI CTCAE g rade  TEAEs leading to treatment discontinuation by system organ class and pref erred term  Related TEAEs leading to treatment discontinuation by system organ class and preferred term  TEAEs classified as M edical Event of Interest (MEOI) by system organ class and preferred term  TEAEs resulting in death by system organ class and preferred term TEAEs will be summarized by presenting the number and percentage of subjects having at least one TEAE in each system organ class and preferred term. A subject with multiple occurrences of the same TEAE will be counted only once in the AE cat egory. Separate TEAE summaries will be presented by system organ class, preferred term, and maximum CTCAE (4.03 or higher ) grade. A subject with multiple CTCAE grades for the same TEAE will be summarized under the maximum CTCAE grade recorded for the event . AEs will also be listed for individual subjects, along with information regarding onset, duration, grade, relationship to the study drug, and outcome. 8.3.2 Clinical Laboratory Evaluations All laboratory values will be converted to SI units and classified as normal, low, or high based on the normal ranges of local /central lab. All gradable laboratory parameters will be graded using the NCI CTCAE v4.03 or higher . The worst post -baseline toxicity grade will be summarized for hematologic, chemistry and coagulatio n parameters for all gradable laboratory parameters , otherwise, the worst abnormal will be presented instead. 05FPRF Immune Design Corp. I MDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 34 / 36 Standard descriptive statistics will be presented for clinical laboratory tests, at baseline, each scheduled visit and change from baseline on saf ety set by each treatment arm and overall . If lab results contain symbols like “<”, “>”, ‘>=” or “<=”, extract the numeric value as the limit, Example: if result is “>0.1”, “0.1” will be used for analysis. Subject listing s of laboratory test results for hematology, chemistry, urinalysis, coagulation and other laboratory tests will be provided separately.