Table 3.
Summary of any adverse events (AEs), their grade (A), type of AEs in > 3% of all patients (B), and immune-related AEs (irAEs) in ≥ grade3 (C) during treatment with ICIs in the 1181 total patients
| Total n, 573 (100%) | |
|---|---|
| n (%) [% of patients with toxicity] | |
| A. General summary of any AEs and their grade | |
| Type of AE | |
| AE only | 329 (57.42%) |
| irAE only | 152 (26.53%) |
| AE and irAE | 92 (16.06%) |
| Severity | |
| Grade 1 | 212 (17.95%) [37.0] |
| Grade 2 | 248 (21.00%) [43.3] |
| Grade 3 | 96 (8.13%) [16.8] |
| Grade 4 | 10 (0.85%) [1.7] |
| Grade 5 | 7 (0.59%) [1.2] |
| ≥ Grade 3 | 113 (9.57) [19.7] |
| Type of AE | Total n, 573 (100%) |
|---|---|
| n (%) | |
| B. Any AEs with incidence > 3% in all patients | |
| Skin rash or skin problem | 69 (12.04%) |
| Asthenia or fatigue | 49 (8.55%) |
| Pneumonitis | 34 (5.93%) |
| Pruritis | 32 (5.58%) |
| Dyspnea or DOE | 30 (5.24%) |
| Hypothyroidism | 26 (4.54%) |
| irAE | Total n = 36 (1.5% of all irAEs) |
|---|---|
| n (%) | |
| C. Summary of irAEs ≥ grade 3 | |
| Pneumonitis | 16 (44.44%) |
| Skin rash or skin problem | 5 (13.89%) |
| Diarrhea | 1 (2.78%) |
| Ulcerative colitis | 1 (2.78%) |
| Hepatitis | 1 (2.78%) |
| Other | 12 (33.33%) |