Table 2

Treatment effect of nivolumab compared with ipilimumab in the presence and absence of select TRAEs

Select TRAE status and treatment armRFS HR (95% CI)*P value†
Select TRAE
 Ipilimumab1
 Without/before select TRAE0.96 (0.61 to 1.51)0.1400
 After select TRAE0.65 (0.51 to 0.83)
Skin select TRAEs
 Ipilimumab1
 Without/before skin select TRAEs0.81 (0.62 to 1.08)0.0716
 After skin select TRAEs0.55 (0.41 to 0.76)
Gastrointestinal select TRAEs
 Ipilimumab1
 Without/before gastrointestinal select TRAEs0.62 (0.49 to 0.80)0.2451
 After gastrointestinal select TRAEs0.81 (0.56 to 1.19)
Select TRAEs with corticosteroid or immunosuppressant use
 Ipilimumab1
 Without/before select TRAEs with corticosteroid or immunosuppressant use0.62 (0.47 to 0.82)0.1412
 After select TRAEs with corticosteroid or immunosuppressant use0.87 (0.61 to 1.24)
Select TRAEs without corticosteroid or immunosuppressant use
 Ipilimumab1
 Without/before select TRAEs without corticosteroid or immunosuppressant use0.96 (0.67 to 1.39)0.0392
 After select TRAEs without corticosteroid or immunosuppressant use0.60 (0.47 to 0.78)

  • *Cox model was used which included treatment indicator, a time-varying indicator for select TRAEs and the interaction term between the variables; Cox model was adjusted for AJCC-7 stage provided at randomization, sex, and age; HR is nivolumab over ipilimumab.

  • †P value is calculated for the test of an HR difference in the presence and absence of TRAEs (ie, the difference between the 2 HRs). Due to multiple hypothesis testing, the Bonferroni-adjusted significant p value for each test is 0.01.

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