Yamada A et al., (2006). Nonmutated self- antigen -derived cancer vaccine peptides elicit an IgE -independent but mast cell- dependent immediate -type skin reaction without systemic anaphylaxis. J Immunol: 176:857-863 CT TG01 -01 Version v 10.0 27 June 2018 Confidential 85 / 87 APPENDIX I: FURTHER GUIDANCE ON THE DEFINITION OF A SERIOUS ADVERSE EVENT (SAE) Life threatening ‘Life -threatening’ means that the patient was at immediate risk of death from the adverse event as it occurred or it is suspected that use or continued use of the product would result in the patient’s death. ‘Life -threatening’ does not mean that had an adverse event occurred in a more severe form it might have caused death (i.e.