• Requires hospitalization or prolongation of existing hospitalization Note: In general, hospitalization signifies that the subject has been detained at the hospital or emergency ward for observation or treatment that would not have been appropriate in the physician’s office or out -patient setting. Complications that occur during hospitalization are AEs but not necessarily Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 52 SAEs. An occurrence or complication that prolongs hospitalization is an SAE. When there is doubt as to whether hospitalization occurred or was necessary, the AE should be considered an SAE. Hospitalizati on for elective treatment of a preexisting condition that did not worsen from its original baseline severity is not considered an SAE. Hospital admissions for overnight monitoring following CRS -207 infusion will not be considered an SAE unless the event me ets criteria for seriousness other than hospitalization. • A persistent or significant disability or incapacity Note: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include AEs of relatively minor medical significance, such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, or accidental trauma (e.g. sprained ankle), that may interfere or prevent everyday life functions, but do not constitute a substantial disruption of a person’s ability to conduct normal life functions. • A congenital anomaly or birth defect • Other important medical event Note: Medical or scientific judgment should be exercised in deciding whether reporting is appropriate for other i mportant medical events that may not result in death, be life -threatening, or require hospitalization but still may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed in this definition. These events should also be considered serious. An SAE requires additional detailed reports and follow -up. The content of these detailed reports must address the investigator’s estimate of causality. 6.3 RECORDING AEs AND SAEs All AEs will be reported from the time study treatment is first administered to the subject (PV1 for Cohort 1 or XP1 for Cohort 2) through 28 days after receipt of final dose of investigational product. Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 53 All preexisting medical conditions will be recorded on the baseline physical examination page of the C RF. Starting with the first administration of first investigational product, any new event or experience that was not present at screening, or worsening of an event present at screening, is considered to be an AE. Unchanged, chronic conditions are not AEs and should not be recorded on the AE page of the CRF. When an AE or SAE occurs, it is the responsibility of the investigator to review all documentation (e.g. hospital progress notes, laboratory and diagnostic reports) relative to the event. The investi gator is to record all relevant information about any AE (including SAEs) on the AE page of the CRF. It is not acceptable for the investigator to send photocopies of the subject’s medical records in lieu of the proper completion of the appropriate AE (or SAE) CRF pages. However, there may be instances where copies of medical records for certain cases are requested. In such instances, all subject identifiers and PHI will be blinded on the copies of the medical records before submission to the appropriate authorities. The investigator will also attempt to establish a diagnosis of the event on the basis of signs, symptoms, or other clinical information. In such cases, the diagnosis, not the individual signs and symptoms, should be documented on the appropri ate CRF as the AE or SAE. In addition, SAEs need to be reported on the SAE report form provided in the study procedures manual ( SPM ). The SPM provides additional guidelines. 6.4 ASSESSMENT OF GRADE The investigator will make an assessment of grade for each AE and SAE reported during the study, which will be recorded in the CRF. The assessment will be based on the National Cancer Institute’s CTC AE, Version 4.03, and graded as shown below: • Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnos tic observations only; intervention not indicated • Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age -appropriate instrumental activities of daily living • Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self -care activities of daily living Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 54 • Grade 4: Life-threatening consequences; urgent intervention indicated • Grade 5: Death related to AE Any AE that changes in grad e during its course will be recorded in the CRF at the highest level experience by the subject. 6.5 ASSESSMENT OF CAUSALITY The investigator is obligated to estimate the relationship between the investigational products and the occurrence of each AE or SAE by using his or her best clinical judgment. Other causes, such as the history of the underlying disease, concomitant therapy, other risk factors, and the temporal relationship of the event to the investigational products will be considered and investigated. The investigator will also consult the IB or product labeling information for marketed products in the determination of the assessment. There may be situations when an SAE has occurred and the investigator has minimal information to include in the initial report. However, it is very important that the investigator always assess causality for every event before the transmission of the SAE. The investigator may change his or her opinion of the causality in light of follow -up information, amending the SAE report. The causality assessment ( Table 3 ) is one of the criteria used to determine regulatory reporting requirements and should not be left blank. Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 55 Table 3. Assessment of Causality/Relatedness of AEs Term Definition Definitely related The AE is clearly related to the investigational agent(s) or research intervention: the AE has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a known pattern of response, and no alternative cause is present. Probabl y related The AE is likely related to the investigational agent(s) or intervention: the AE has a temporal relationship to the administration of the investigational agent(s) or research intervention and follows a known or suspected pattern of response, but an alternative cause may be present . Possibly related The AE may be related to the investigational agent(s) or intervention: the AE has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a suspected pattern of response, but an a lternative cause is present. Unlikely to be related The AE is doubtfully related to the investigational agent(s) or intervention: the AE has a temporal relationship to the administration of the investigational agent(s) or research intervention but follows no known or suspected pattern of response, and an alternative cause is present. Unrelated (or not related) The AE is clearly NOT related to the investigational agent(s) or intervention: the AE has no temporal relationship to the administration of the investigational agent(s) or research intervention and follows no known or suspected pattern of response, and an alternative cause is present. AE = adverse event. 6.6 REPORTING OF SAEs Reporting of SAE s will begin at the time study treatment is first administered to the subject (PV1 for Cohort 1 or XP1 for Cohort 2) and will continue through 28 days after receipt of final dose of investigational product. SAEs will be reported to the sponsor by phone, fax, or e -mail within 24 hours of the time the investigator becomes aware of the event. SAE Reporting Fax Number: 510-295-2666 The Medical Monitor may also be contacted to discuss a safety event: Jackie Walling, MBChB, PhD : mobile: 650-483-9726 The urgency for reporting SAE(s) is fourfold: 1. To enable the safety department to fulfill the reporting requirements to the appropriate regulatory authority Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 56 2. To facilitate discussion (and implementation, if necessary) between the safety department and the investigator of appropriate follow -up measures in the event an expedited report is required 3.