Table 1

Nivolumab treatment effect in the absence compared with the presence of select treatment-related adverse events

Select TRAE typeNivolumab RFS HR (95% CI)*P value†
Any select TRAE0.97 (0.70 to 1.34)0.8583
Skin select TRAEs1.27 (0.91 to 1.76)0.1577
Gastrointestinal select TRAEs0.89 (0.62 to 1.28)0.5355
Select TRAEs with corticosteroid or immunosuppressant use0.76 (0.52 to 1.09)0.1319
Select TRAEs without corticosteroid or immunosuppressant use1.06 (0.77 to 1.46)0.7063
  • *Cox model was used which included a time-varying indicator for select TRAEs; Cox model was adjusted for AJCC-7 stage provided at randomization, sex, and age; HR is absence over presence of TRAEs.

  • †P value is calculated for the time-varying indicator for select TRAEs. Due to multiple hypothesis testing, the Bonferroni-adjusted significant p value for each test is 0.01.

  • RFS, recurrence-free survival; TRAE, treatment-related adverse event.