Skip to main content

Table 2 Reporting of clinical consequences of toxicity

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

Patients Who Experience Toxicity
Adverse Event Dose Delay (No. and Proportion of patients Dose Discontinuationa No. and proportion patients) Timing of Toxicity Onset (median and range)b Use of High-Dosec Steroids (No. and proportion of patients Duration of High-Dose Steroid Use (median and range Duration of Dose Taperingd (median and range) Additional Immune- Suppressing Agents (No. and proportion of patients who required escalation beyond steroids; specify drugs) Time to Resolution of Toxicitye (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          
  1. aDefined as the inability to continue on the protocol; may include irreversible toxicity and toxicity resulting in ineligibility for subsequent treatment
  2. bDays from cycle 1, day 1 to time of onset (include cycle, day and period from initiation of treatment)
  3. cDefined as at least 40 mg prednisone equivalents per day
  4. dIf the protocol required collecting this information
  5. 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)