0 Dead. DF/HCC Protocol #: 18-280 Protocol Version Date: 10.17.2020 41 APPENDIX B: DOSE MODIFICATIONS FOR NIVOLUMAB-RELATED AES DF/HCC Protocol #: 18-280 Protocol Version Date: 10.17.2020 42 DF/HCC Protocol #: 18-280 Protocol Version Date: 10.17.2020 43 DF/HCC Protocol #: 18-280 Protocol Version Date: 10.17.2020 44 DF/HCC Protocol #: 18-280 Protocol Version Date: 10.17.2020 45 Adverse Reaction Severity Dose Delays Other – excluding hematologic toxicities Other Grade 3 adverse reaction: First occurrence Withhold dose and resume when AE returns to Grade 0 or 1 Recurrence of same grade 3 adverse reaction1 Permanently discontinue Life-threatening or Grade 4 adverse reaction Permanently discontinue Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks Permanently discontinue Persistent Grade 2 or 3 adverse reactions lasting 12 weeks or longer Permanently discontinue 1. Laboratory abnormalities determined to be not clinically significant are not subject to this criteria, hematologic in nature or otherwise.