This is a coversheet for all reports submitted as required. 2. Par ticipating institutions internal serious adverse event form. This is the form/report that the participating institutions submit to their IRB of record. 3. A dverse Event/Unanticipated Problem Reporting Form (Appendix “B”). The participating institution will notify their local IRB as per their local established guidelines and include a copy of the completed Dendreon SAE Form. The Data Coordinating Center at City of Hope will send a copy of the participating institutions serious adverse event (reported via Dendreon SAE Form and institutional SAE report) to the following internal departments: Page 26 of 50 IRB Protocol No. 12367 Version Date: 10/24/2017 Version: 09 C ity of Hope IRB and DSMC (as applicable) City of Hope Office of IND Development and Regulatory Affairs (as applicable) Any supporting documentation to the reports (i.e., laboratory, pathology, progress notes, discharge summary, autopsy, etc.) explaining the adverse event should also be submitted to the Data Coordinating Center at City of Hope. The Data Coordinating Center will then submit to our COH IRB/DSMC. 8.0 Agent Information and Risks 8.1 Sipuleucel –T (Provenge®) 8.1.1 Sipuleucel-T overview Sipuleucel- T (Provenge ®) is commercially available autologous therapeutic cancer vaccine made of recombinant fusion protein consisting of human PAP and GM-CSF. GM-CSF acts as a targeting molecule that directs the PAP antigen to APCs and promotes antigen uptake and processing.