Table 2. Frequency of immune-related adverse events and time of onset.
| Immune-related adverse event | Any grade, N (%) | Median onset, weeks (range) | Grade 3-4, N (%) | Median onset, weeks (range) |
|---|---|---|---|---|
| Arthralgia | 13 (13.4) | 3.0 (1.4–34.8) | 1 (1.0) | 3.0 |
| Diarrhea/colitis | 12 (12.4) | 7.9 (3.0–76.0) | 1 (1.0) | 8.9 |
| Hepatotoxicity* | 7 (7.2) | 6.1 (2.7–11.9) | 2 (2.1) | 5.0 (3.7–6.3) |
| Hypersensitivity | 3 (3.1) | 8.1 (2.4–12.3) | 0 (0.0) | – |
| Hyperthyroidism | 4 (4.1) | 3.4 (1.6–5.9) | 0 (0.0) | – |
| Hypothyroidism | 9 (9.3) | 12 (5.9–15.9) | 0 (0.0) | – |
| Infusion reaction | 6 (6.2) | 1.9 (0–2.4) | 1 (1.0) | 2.0 |
| Nephritis | 1 (1.0) | 11.9 | 0 (0.0) | – |
| Pneumonitis | 5 (5.2) | 16.9 (0.6–72.3) | 1 (1.0) | 0.6 |
| Pruritis | 10 (10.3) | 6.4 (0–66.0) | 0 (0.0) | – |
| Pyrexia | 5 (5.2) | 1.9 (0.7–2.0) | 0 (0.0) | – |
| Skin rash** | 11 (11.3) | 5.7 (0–84.0) | 2 (2.1) | 61.8 (39.6–84.0) |
*, including transaminitis, hepatitis, hyperbilirubinemia; **, including psoriasis.