This form can be found on the QACT website or obtained from the QACT registration staff. Protocol A pilot study to evaluate PBR PET as an indicator of inflammation in brain tumor patients treated with chemoradiation or immunotherapy. Version Date: June 20, 2018 17 DOSING DELAYS/DOSE M ODIFICATIONS No dose modifications will be made to the PBR dosing. ADVERSE EVENTS: LIST AND REPORTING REQU IREMENTS Adverse event (AE) monitoring and reporting is a routine part of every clinical trial. The following list of reported and/or potential AEs (Section 7.1) and the characteristics of an observed AE (Section 7.2) will determine whether the event requires expedited reporting in addition to routine reporting. Per NCI Adverse Event Reporting Requirements related to PET tracers , adverse events related to the PET imaging are reportable up to 3.5 hours after injection (i.e. 10 half-lives of the C11 tracer). 7.1 Expected Toxicities 7.1.1 Adve rse Events List 7.1.1.1 Adverse Event List for PBR There are no known adverse events related to PBR. 7.1.1.2 Adverse Event List (s) for Other Agent(s) NA 7.2 Adverse Event Characteristics • CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm . • For expedited repor ting purposes only: - AEs for the agent (s) that are listed above should be reported only if the adverse event Protocol A pilot study to evaluate PBR PET as an indicator of inflammation in brain tumor patients treated with chemoradiation or immunotherapy. Version Date: June 20, 2018 18 varies in nature, intensity or frequency from the expected toxicity information which is provided. - Other AEs for the protocol that do not require expedited reporting are outlined in the next section (Expedited Adverse Event Reporting) under the sub- heading of Protocol- Specific Expedited Adverse Event Reporting Exclusions. • Attribution of the AE: - Definite – The AE is clearly related to the study treatment. - Probable – The AE is likely related to the study treatment. - Possible – The AE may be related to the study treatment. - Unlikely – The AE is doubtfully related to the study treatment. - Unrelated – The AE is clearly NOT related to the s tudy treatment. There are no known adverse events related to PBR28 but any event thought related to PBR28 that is CTCAE grade ≥3 will be considered a serious adverse event and should be reported to the Overall PI and RDRC per the DFCI IRB reporting policy. 7.3 Expedited Adverse Event Reporting Per NCI Adverse Event Reporting Requirements related to PET tracers, investigators must report to the Overall PI any serious adverse event (SAE ) related to the PET imaging up to 3.5 hours after injection (i.e. 10 half -lives of the C11 tracer). Thus, by 3.5 hours after injection the tracer should be out of a patients system and not responsible for any adverse events. Any SAE s related to the PET imaging will also be reported to the RDRC. 7.3.1 DF/HCC Expedited Reporting Guidelines Investigative sites within DF/HCC and DF/PCC will report SAEs directly to the DFCI Office for Human Research Studies (OHRS) per the DFCI IRB reporting policy . 7.3.2 Protocol -Specific Expedited Adverse Event Reporting Exclusions For this protocol only, the AEs/grades listed below do not require expedited reporting to the Overall PI or the DFCI IRB . However, they still must be reported through the routine reporting mechanism (i.e.