Confirmation**CR Not evaluated No PR PR Non-CR/Non- PD/not evaluatedNo PR SD Non-CR/Non- PD/not evaluatedNo SD Documented at least once >4 wks. from baseline** PD Any Yes or No PD no prior SD, PR or CR Any PD*** Yes or No PD Any Any Yes PD * See RECIST v1.1 manuscript for further details on what is evide nce of a new lesion. ** Only for non-randomized trials with response as primary endpoint. *** In exceptional circumstances, unequivocal progression in non -target lesions may be accepted as disease progression. Note: Patients with a global deterioration of health status requ iring discontinuation of treatment without objective evidence of disease progression at that time should be reported as “symptomatic deterioration.” Every effort should be made to document the objective progression even after discontinuation of treatment. 6.3.5 Duration of Response Duration of overall response: The duration of overall response i s measured from the time measurement criteria are met for CR or PR (whichever is first r ecorded) until the first date that recurrent or progressive diseas e is objectively documented (tak ing as reference for progressive disease the smallest measurements recorded since t he treatment started). The duration of overall CR is measur ed from the time measuremen t criteria are first met for CR until the first date that prog ressive disease is objectively do cumented. Duration of stable disease: Stable disease is measured from the start of the treatment until the criteria for progression are met , taking as reference the small est measurements recorded since the treatment started, i ncluding the baseline measurements. TOXICITY CRITERIA The following adverse event mana gement guidelines are intended to ensure the safety of each patient while on the study. The des criptions and grading scales found in the revised NCI Common Terminology Criteria for A dverse Events (CTCAE) version 5.0 will be utilized for AE reporting. All appropriate trea tment areas should have access to a copy of the CTCAE version 5.0. A copy of the CTCAE versi on 5.0 can be downloaded from the CTEP web site (http://ctep.cancer.gov/protocolDevelopment/electronic_applicati ons/ctc.htm ). Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 327 SAFETY REPORTING REQUIREMENTS/DATA AND SAFETY MONITORING PLAN DEFINITIONS 7.1.1 Adverse Event An adverse event is defined as any untoward medical occurrence in a human subject, including any abnormal sign (for example , abnormal physical exam or labor atory finding), symptom, or disease, temporally associated w ith the subject’s participation in research, whether or not considered related to the subject ’s participation in the resear ch. 7.1.2 Suspected Adverse ReactionSuspected adverse reaction means any adverse event for which th ere is a reasonable possibility that the drug caused the advers e event. For the purposes of IND safety reporting, ‘reasonable possibility’ means there is evidence to suggest a causal relatio nship between the drug and the adverse event. A suspected adve rse reaction implies a lesser de gree of certainty about causality than adverse reaction, which mean s any adverse event caused by a drug. 7.1.3 Unexpected Adverse ReactionAn adverse event or suspected adv erse reaction is considered “u nexpected” if it is not listed in the investigator brochure or i s not listed at the specificity o r severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application. "Unexpected” also refers to adve rse events or suspected adverse reactions that are mentioned in the investigator brochure as o ccurring with a class of drugs or as anticipated from the pharmacological properties of the drug, but are not specificall y mentioned as occurring with the particular drug und er investigation. 7.1.4 Serious An Unanticipated Problem or Protocol Deviation is serious if it meets the definition of a Serious Adverse Event or if it compromis es the safety, welfare or right s of subjects or others. 7.1.5 Serious Adverse EventAn adverse event or suspected adv erse reaction is considered se rious if in the view of the investigator or the sponsor, it results in any of the following : xDeath, xA life-threatening adverse drug experience xInpatient hospitalization or prolongation of existing hospitali zation xPersistent or significant incap acity or substantial disruption of the ability to conduct normal life functions xA congenital anomaly/birth defect. xImportant medical events that m ay not result in death, be life- threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, t hey may jeopardize the patient or subject and may require medical or surgical interventi on to prevent one of the outcomes listed in this definition. Abbreviated Title: Personalized DC Vaccine Version Date: March 26, 2018 337.1.6 Disability A substantial disruption of a pe rson’s ability to conduct norma l life functions. 7.1.7 Life-Threatening Adverse Drug ExperienceAny adverse event or suspected adverse reaction that places the patient or subject, in the view of the investigator or sponsor, at immediate risk of death from th e reaction as it occurred, i.e., it does not include a reac tion that had it occurred in a more seve re form, might have caused death. 7.1.8 Protocol Deviation (NIH Definition)Any change, divergence, or departure from the IRB-approved research protocol. 7.1.9 Non-Compliance (NIH Definition)The failure to comply with appli cable NIH Human Research Protec tions Program (HRPP) policies, IRB require ments, or regulatory requirements for the protection of human research subjects. 7.1.10 Unanticipated ProblemAny incident, experie nce, or outcome that: xIs unexpected in terms of nature, s everity, or frequency in rel ation to: (a) the research risks that ar e described in the IRB-approved r esearch protocol and informed consent document; Inves tigator’s Brochure or other stu dy documents, and (b) the characteristics of t he subject population being studied ; AND xIs related or possibly related t o participation in the research ; AND xSuggests that the research places subjects or others at a great er risk of harm (including physical, psychological, economic, or social harm) than was prev iously known or recognized. NCI-IRB R EPORTING AND CLINICAL DIRECTOR (CD) R EPORTING 7.2.1 NCI-IRB and NCI CD Expedited R eporting of Unanticipated Pr oblems and Deaths The Protocol PI will report in the NIH Problem Form to the NCI- IRB and NCI Clinical Director: xAll deaths, except deaths due to progressive disease xAll Protocol Deviations xAll Unanticipated Problems xAll non-compliance Reports must be received withi n 7 days of PI awareness via iRIS . 7.2.2 NCI-IRB Requirements for PI Reporting at Continuing ReviewThe protocol PI will report to the NCI-IRB: 1. A summary of all protocol deviations in a tabular format to i nclude the date the deviation occurred, a brief description of the deviation and any correcti ve action.