Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement

Table 2 Reporting of clinical consequences of toxicity

Patients Who Experience Toxicity
Adverse Event	Dose Delay (No. and Proportion of patients	Dose Discontinuation^a No. and proportion patients)	Timing of Toxicity Onset (median and range)^b	Use of High-Dose^c Steroids (No. and proportion of patients	Duration of High-Dose Steroid Use (median and range	Duration of Dose Tapering^d (median and range)	Additional Immune- Suppressing Agents (No. and proportion of patients who required escalation beyond steroids; specify drugs)	Time to Resolution of Toxicity^e (median and range, percent of patients with unresolved toxicity)	Emergency Center Visit/ Hospitalization (No. and proportion of patients)
Adverse event 1
(e.g., colitis)
Adverse event 2
Adverse event 3
Adverse event 4

^aDefined as the inability to continue on the protocol; may include irreversible toxicity and toxicity resulting in ineligibility for subsequent treatment
^bDays from cycle 1, day 1 to time of onset (include cycle, day and period from initiation of treatment)
^cDefined as at least 40 mg prednisone equivalents per day
^dIf the protocol required collecting this information
^eDefine specifically if “resolution” refers to return to grade 1 or 0 (indicate whether this includes patients who are on steroids to manage adverse events)