Totally confined to bed or chair. 58 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 Appendix G Data Safety Monitoring Plan This is a free standing document 59 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 Appendix H Adverse Events Reporting Algorithm 60 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 Appendix I MedWatch FDA Form 3500 Link http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/ucm082728.pdf 61 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 APPENDIX J Study Flowchart Days –60 to –1 Week 1 (Day 0) DTH Pre/Post (6) vaccines 2 Every 3 Weeks Every 3 Months Every 6 Months If Clinically Indicated Final Visit in 36th month Hematology (CBC, diff., platelets)1 X x X1 Chemistry panel (CMP) X X X1 HLA blood draw for typing During study screening process/patient identification process. Immunological Samples2 X2 X2 X2 Trastuzumab administration (q3 weeks) X DTH administration3 1, 23 Vaccine administration4 X4 Booster inoculations 5 X5 Post-Booster Immunological Samples2 X2 Complete medical history (treating physician) X X Complete physical exam (treating physician, based on SOC) X X X X Clinical assessment-Study nurse visit4,5,10 X X4 X4 X5 X10 Weight, height (treating physician) X X ECOG performance status X Toxicity evaluation9,10 X9 X9 X9 X9 X10 Vital signs9 X9 X9 X9 Cardiac Assessment (MUGA scan or Echo)6 X X6 Chest X-ray (AP, lateral)/EKG X Urine pregnancy test (if applicable)7 X7 X7 X7 X7 Tumor assessment (treating physician)8 X8 X Disease status monitoring8,10 X8 X8 X8 X8 X10 1 Per standard practice, all patients will have CBC/CMP monitored approximately every 3 months during the primary series and approximately every 6 months during the booster phase. 2Immunological samples will be drawn pre DTH#1 and #2, prior to each of 4 boosters, 1 month (+/-1 week) after each booster, and at study completion 36 months after initiation of Trastuzumab maintenance therapy. 3DTH #1 given prior to initiation of primary vaccine series, one month (+/- 1 week) after completion of primary vaccine series, and one month (+/-1 week) after the final booster inoculation. 4Vaccine inoculation administered every 3 weeks for 6 inoculations during trastuzumab treatment schedule. Vaccine inoculations to begin with 3rd dose of maintenance trastuzumab infusion, optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumab to overlap 62 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 with the PVS. Vaccine inoculations given within 30-120 minutes after completion of infusion. (With prior approval from the Principal Investigator, the vaccine may be administered 15 minutes after completion of trastuzumab infusion). 5Booster inoculations will be given after initial vaccine series, every 6 months x4, beginning 6 months (+/- 2 weeks) after the completion of the Primary Vaccine Series Subsequent boosters will be given at 12, 18, and 24 months (+/- 2 weeks), after the completion of the PVS. 6All patients will have cardiac assessment performed according to standard practice as dictated by their treating oncologist.