Nivolumab treatment effect in the absence compared with the presence of select treatment-related adverse events
| Select TRAE type | Nivolumab RFS HR (95% CI)* | P value† |
| Any select TRAE | 0.97 (0.70 to 1.34) | 0.8583 |
| Skin select TRAEs | 1.27 (0.91 to 1.76) | 0.1577 |
| Gastrointestinal select TRAEs | 0.89 (0.62 to 1.28) | 0.5355 |
| Select TRAEs with corticosteroid or immunosuppressant use | 0.76 (0.52 to 1.09) | 0.1319 |
| Select TRAEs without corticosteroid or immunosuppressant use | 1.06 (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.