summary letter). Long -Term Fol low-Up Protocol All patients that have received GVAX will also be encouraged to enter a separate long -term follow -up protocol to assess for potential late toxicities of GVAX ( e.g. autoimmune disease, second malignancies). This long -term follow -up protocol will involve annual visits for 3 years after the last dose of GVAX has been administered to a given patient . 7.5.4 RAC reporting requirements All AEs and SAEs will be reported to the Johns Hopkins Institutional Biosafety Committee (IBC) per current institu tional standards, and to the Recombinant DNA Advisory Co mmittee (RAC) as described in Section 7.5.3. These reporting procedures will be in accordance with Appendix M of the NIH Guidelines for Research Involving Recombinant DNA Molecules (http://oba.od.nih.gov/oba/rac/guidelines_02/APPENDIX_M.htm#_Toc7255846 ). 7.6 Pregnancy Pregnancy is not an AE unless it results in congenital anomaly or birth defect, in which case it is a SAE. If the partner of a male patient should become pregnant while he is participating in the study, the patient should infor m his treating physician immediately . All pregnancies must be reported at once to the principal investigator and medical monitor. All confirmed pregnancies will be followed until birth or until voluntary or spontaneous termination.