Table 2.
Incidence of immune-related adverse events over 12 months
| Immune-related AE category | No. of patients, n (%) | No. of events | ||||
|---|---|---|---|---|---|---|
| Any grade | Grade ≥ 3 | All grade, n | Median (range) time to onset, weeks | Resolved, n (recovery rate, %) | Median (range) time to resolution, weeks | |
| Any immune-related AE | 38 (14.8) | 15 (5.9) | 47 | 8.7 (0.1–43.7) | 34 (72.3) | 4.8 (0–43.4) |
| Endocrine disorder | 14 (5.5) | 2 (0.8) | 14 | 9.3 (0.1–43.0) | 9 (64.3) | 5.1 (1.4–12.0) |
| Lung disorder | 8 (3.1) | 6 (2.3) | 8 | 3.0 (0.3–27.3) | 4 (50.0) | 4.8 (3.0–11.3) |
| Skin disorder | 7 (2.7) | 2 (0.8) | 8 | 21.2 (4.0–33.1) | 6 (75.0) | 2.5 (2.0–22.0) |
| Liver disorder | 6 (2.3) | 3 (1.2) | 7 | 12.0 (2.0–29.0) | 7 (100.0) | 4.7 (0.7–27.3) |
| Gastrointestinal disorder | 3 (1.2) | 1 (0.4) | 3 | 9.4 (9.0–43.7) | 3 (100.0) | 6.4 (0–14.0) |
| Blood disorder | 2 (0.8) | 1 (0.4) | 2 | 5.8 (4.0–7.6) | 1 (50.0) | 43.4 (43.4–43.4) |
| Other | 5 (2.0) | 2 (0.8) | 5 | 4.0 (2.0–29.0) | 4 (80.0) | 3.1 (0–27.0) |
Time to onset refers to the time after the first dose of nivolumab and time to resolution refers to time from the onset of the adverse event until complete resolution
AE adverse event