5.12.3. CRS- 207 Infusion-r elated Reactions CRS- 207 infusion- related reactions (fever, chills, rigors, nausea, vomiting, hypotension) that occur red within 2 days of the infusion will be summarized based on data recorded on applicable CRF pages . These AEs will be graded and coded in the same manner as general AEs. The tabulation will include a count of the number of subjects with infusions, incidences of maximum grades for infusion- related reactions, as well as numerical summaries of the number of infusions and infusion- related reactions for subjects . An incidence table for infusion- related reactions similar to those specified for general AEs, by PT in decreasing order of overall frequency , will be present ed. Denominators for percentages include subjects with 1 or more CRS- 207 infusions. A comprehensive by -subject data listing of all CRS- 207 infusion- related reactions will be provided. Aduro Biotech, Inc. CONFIDENTIAL Protocol ADU -CL-02 Final Version 1 Page 20 of 24 04MAY2018 5.12.4. Dose Limiting Toxicities If data allows, CRS- 207 DLTs will be presented in a data listing. As defined in Section 3.6 of the study protocol, DLTs are events determined by the investigator as related to CRS -207 that meet one of the following criteria: • A fever of >40°C that lasts for greater than 24 hours and does not respond t o antipyretics • Clinically significant hypotension unresponsive to intravenous fluids (e.g., systolic blood pressure <90 mmHg or mean arterial pressure <55 mmHg as measured on two separate occasions at least 10 minutes apart) • Grade 3 or greater decreases in leukocytes, absolute neutrophil count ( ANC) , or platelets that persist for more than 4 days • Hemoglobin ≤7.0 g/dL • Alanine aminotransferase ( ALT), aspartate aminotransferase ( AST), or alkaline phosphatase elevations >5 times the upper limit of normal ( ULN) (Grade 3) that persist for more than 7 days • Initiation of antibiotic therapy, coincident with simultaneous isolation of CRS -207 from a normally sterile body site, other than blood (e.g., cerebrospinal fluid, joint fluid) • Unexpected Grade 3 laboratory abnormalities lasting >48 hours • Grade 3 or greater hypophosphatemia or lymphopenia that persist for more than 7 days • Any other Grade 3 or greater event according to National Cancer Institute’s CTCAE Version 4.03 5.12.5. Laboratory Data Hematology and serum chemistry parameters will be converted according to the International System of Units (SI) and will be listed by cohort and subject . Shift tables displaying the shift from baseline to the worst value by NCI CTCAE grade will be presented for the Treatment Period. The worst value is defined as the maximum NCI CTCAE grade based upon the worst observation post -baseline while on study . “Worst” can be defined as “high/hyper ” or “low /hypo” (or bilaterally) and will be specified within the parameter being summarized. Separate shift tables will be prepared for shifts to the worst low toxicity and to the worst high toxicity for lab parameters with bi - directional toxicity grading. 5.12.6. Vital Signs and Physical Examinations Physical examination data will be provided in a by -subject data listing. Vital signs data will be provided in a by -subject data listing. Aduro Biotech, Inc. CONFIDENTIAL Protocol ADU -CL-02 Final Version 1 Page 21 of 24 04MAY2018 5.12.7. Electrocardiogram Resting 12- lead ECG data will summarized by a shift table of baseline to worst result during the Treatment Period with the categories of ‘normal,’ ‘abnormal, not clinically significant,’ and ‘abnormal, clinically significant .’ 5.12.8. ECOG Performance Status ECOG data will be provided in a by -subject data listing. Aduro Biotech, Inc. CONFIDENTIAL Protocol ADU -CL-02 Final Version 1 Page 22 of 24 04MAY2018 6. CHANGES TO PLANNED ANALYSES Changes to the protocol -specified statistical analyses are as follows: • Primary and secondary efficacy endpoints will not be evaluated; tumor and overall response data, based on mRECIST alone, will be listed. Analysis of immune response to mesothelin, the predictive value of serum mesothelin, and all exploratory endpoints corresponding to exploratory objectives identified in Section 2.3, with exception of that corresponding to pulmonary function, will be discussed in a standalone document . • The per protocol population will no longer be evaluated.