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. 2020 Jan 2;6(4):519–527. doi: 10.1001/jamaoncol.2019.5570

Figure 2. Incidence of Immune-Related Adverse Events by Treatment Arm Among All Patients and Subgroups of Patients.

Figure 2.

A, In the pembrolizumab arm (n = 509), 190 irAEs occurred, with a percentage incidence of 19.4% (95% CI, 16.1%-23.0%) at 3 months and 37.4% (95% CI, 33.2%-41.6%) at 15 months. In the placebo arm (n = 502), 45 irAEs occurred, with a percentage incidence of 4.0% (95% CI, 2.5%-6.0%) at 3 months and 9.0% (95% CI, 6.7%-11.7%) at 15 months. Vertical lines correspond to the time of censoring. B, The estimate of the subdistribution hazard ratio in the whole sample is based on an unstratified model with treatment as the only covariate. Blue boxes are centered on the estimated subdistribution hazard ratios. The green diamond is centered on the overall subdistribution hazard ratio (dashed line) and covers its 95% CI. HR indicates hazard ratio; irAE, immune-related adverse event; and LN+, positive lymph node.

aFor the whole sample estimate, a 95% CI is shown. For subgroups, 99% CIs are presented.

bP < .001 corresponds only to the overall comparison, performed on all patients: HR, 4.95 (99% CI, 3.58-6.85).