12 APPENDICES ......................................................................................................... APPENDIX 1 ABBREVIATIONS AND TRADEMARKS ........................................ APPENDIX 2 STUDY GOVERNANCE CONSIDERATIONS ................................. APPENDIX 3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, FOLLOW UP AND REPORTING ......................................................................... APPENDIX 4 WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND METHODS OF CONTRACEPTION ..................................................................... APPENDIX 5 RECIST 1.1 CRITERIA........................................................................