64 17.2.1 Phase II Toxicity Monitoring ....................................................................... 64 17.2.2 Monitoring of Non- Overlapping Vaccine Related Toxicity ........................ 64 17.2.3 Monitoring of Vaccine Related Mortality .................................................... 64 17.2.4 Monitoring of Chemotherapy -Related Mortal ity ......................................... 64 17.3 Management of Toxicities ........................................................................... 64 17.4 Adverse Event Reporting and Documentation ............................................ 66 17.4.1 Adverse events ............................................................................................. 66 17.4.2 serious adverse events .................................................................................. 66 17.4.3 adverse event documentation ....................................................................... 66 17.5 Concomitant Medication ..............................................................................