5.12. Safety Analyses Safety analyses will be conducted using the Safety Analysis set and will be reported by cohort and overall. The safety parameters collected and monitored during this study include AEs and deaths, hematology, serum chemistry, concomitant medications, physical examinations, vital signs and weight, ECOG performance, and 12- lead electrocardiograms (ECGs) . 5.12.1. Adverse Events Adverse events are assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) 4.03. An AE is any reaction, side effect, or other untoward event, regardless of relationship to study drug, that occurs any time during the study. Adverse events occurring at any time from the beginning of any study dosing until 28 days after the final dose of any study treatment are considered TE AEs. If the start date is the same as the date of the first dose of study drug and there is no indication that the AE began before dosing, the event will be considered treatment emergent. Partial start and stop dates will be imputed as described in the section for missing data. If start and stop dates are missing and/or partial date(s) are insufficient to determine treatment emergence, then the AE will be considered treatment -emergent . Verbatim adverse events will be mapped to preferred term (PT) and system organ class (SOC) using MedDRA version 15.0. In incidence summary displays, AEs will be counted only once per subject within MedDRA category (e.g., overall, SOC, and PT ), by the worst CTCAE grade, and/or the strongest relationship to study drug (not related, unlikely related, p ossibly related, p robably related, d efinitely related). Any relationship summaries will be produced for CRS -207 and c yclophosphamide in combination (for any relationship to either study drug). The frequency and percentage of subjects with TE AEs will be tabulated by MedDRA SOC and PT. Tabulations will be prepared by SOC and PT within SOC and will include: Aduro Biotech, Inc. CONFIDENTIAL Protocol ADU -CL-02 Final Version 1 Page 19 of 24 04MAY2018 • All TEAEs • Related TEAEs • Serious TEAEs • Related Serious TEAEs • CTCAE Grade 3 or higher TEAEs • CTCAE Grade 3 or higher related TEAEs • TEAEs with frequency in any cohort >=5% To account for potential differences in the extent of exposure between the treatment categories, a subject -year adjusted rate will also be presented. The rate is calculated as the number of subjects with an event divided by the total subject -years of exposure, where subject -years of exposure for each subject is defined as D uration of Treatment Exposure in days divided by 365.25. Duration of T reatment Exposure for all subject s is defined per total treatment duration in Section 5.2.2. A comprehensive listing of all AEs (including those which are not treatment -emergent) will be provided in a by -subject data listing. In addition, the following listings will be provided: • SAEs • TEAEs leading to death • TEAEs leading to treatment discontinuation Adverse events specifically recorded as CRS -207 infusion- related reactions will be tabulated by frequency (count and percent) using MedDRA SOC and PT. 5.12.2. Deaths The number and percent of subjects who died along with primary cause of death will be summarized overall (including the post -study survival surveillance period) and within 28 days of last dose of study drug. All death data will be listed.