TABLE 4.
irAEs with an incidence of ≥ 2% assessed by investigators in the safety set
| Sintilimab (n = 144) | ||
|---|---|---|
| irAEs, n (%) | All grades | Grade 3‐4 |
| At least one time | 84 (58.3) | 14 (9.7) |
| Laboratory test | 35 (24.3) | 3 (2.1) |
| Increased ALT | 14 (9.7) | 1 (0.7) |
| Increased AST | 15 (10.4) | 1 (0.7%) |
| Diseases of the skin and subcutaneous tissues | 35 (24.3) | 4 (2.8) |
| Skin rash | 17 (11.8) | 2 (1.4) |
| Dermatitis | 4 (2.8) | 2 (1.4) |
| Pruritus | 4 (2.8) | 0 (0) |
| Others | 11 (7.6) | 0 (0) |
| Diseases of the endocrine system | 30 (20.8) | 0 (0) |
| Hypothyroidism | 21 (14.6) | 0 (0) |
| Hyperthyroidism | 11 (7.6) | 0 (0) |
| Systemic diseases and reactions of drug administration sites | 19 (13.2) | 1 (0.7) |
| Fatigue | 9 (6.3) | 0 (0) |
| Others | 12 (8.3) | 1 (0.7) |
| Metabolic and nutritional diseases | 12 (8.3) | 1 (0.7) |
| Loss of appetite | 8 (5.6) | 0 (0) |
| Others | 9 (6.3) | 1 (0.7) |
Note: The number of cases for the row title refers to the number of patients with the corresponding main condition, while the number of cases for the corresponding row subtitle refers to the number of cases with the specified event. Since one patient may have several specified events (including hypo/hyperthyroidism but at different time points during the study period), therefore the number of cases of specified events may surpass the number of cases of main condition events.
“Others” in the table refer to cases that were not mentioned as their occurrence were ≤ 2%.
Abbreviations: irAEs: immune‐related adverse events; ALT: alanine aminotransferase; AST: aspartate aminotransferase.