Totally confined to bed or chair. CONFIDENTIAL Page 91 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 APPENDIX J Case Report Forms These are free standing electronic documents. CONFIDENTIAL Page 92 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 APPENDIX K Data Safety Monitoring Plan This is a free standing document CONFIDENTIAL Page 93 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 REPORT IN WRITING WITHIN 24 HOURS: 1. Local IRB 2.