................................ ..28 9.1 Temporar y halt for reasons of subject safety ................................ .......................... 28 9.2 AEs, AESIs and SUSARs ................................ ................................ ....................... 28 9.2.1 Adverse events (AEs) ................................ ................................ ...................... 28 9.2.2 Serious Adverse events (AEs) ................................ ................................ ......... 28 9.2.3 Adverse events of special interest (AESIs) ................................ ...................... 29 9.2.4 Immune related adverse events (irAEs) ................................ ........................... 30 9.2.5 Suspected unexpected serious adverse reactions (SUSARs) ......................... 30 9.3 Annual safety report ................................ ................................