Table 4.
Comparative immune‐mediated adverse events (any grade) of immune checkpoint inhibitors‐containing group versus chemotherapy group in 12 randomized controlled trials
| Adverse events | No. trials | I group events/pts | C group events/pts | Pooled RR (95%CI) | P‐value |
|---|---|---|---|---|---|
| Hypothyroidism | 9 | 274/2917 | 43/2870 | 5.53 (3.43,8.91) | P < 0.00001* |
| Hyperthyroidism | 6 | 80/1623 | 17/1422 | 3.99 (1.93,8.28) | P = 0.0002* |
| Pneumonitis | 8 | 141/2526 | 25/2300 | 4.33 (2.33,8.05) | P < 0.00001* |
| Infusion reaction | 7 | 50/2133 | 40/1906 | 1.57 (0.68,3.62) | P = 0.29 |
| Severe skin reaction | 7 | 44/2192 | 10/1966 | 3.35 (1.21,9.26) | P = 0.02* |
| Colitis | 7 | 42/2467 | 7/2238 | 3.82 (1.81,8.05) | P = 0.0004* |
| Hypophysitis | 5 | 13/1866 | 0/1641 | 5.17 (1.35,19.81) | P = 0.02* |
| Nephritis | 6 | 21/2133 | 20/1904 | 1.78 (0.42,7.48) | P = 0.43 |
| Pancreatitis | 4 | 10/1588 | 0/1361 | 4.43 (0.96,20.37) | P = 0.06 |
| diabetes mellitus | 4 | 7/1286 | 1/1080 | 2.94 (0.72,12.05) | P = 0.13 |
| Myositis | 3 | 6/952 | 1/746 | 2.68 (0.54,13.37) | P = 0.23 |
| Hepatitis | 4 | 26/1712 | 0/1491 | 11.49 (2.74,48.26) | P = 0.0009* |
| Thyroiditis | 4 | 18/1473 | 0/1247 | 7.14 (1.62,31.48) | P = 0.009* |
| Adrenal insufficiency | 3 | 6/1434 | 5/1211 | 0.99 (0.28,3.44) | P = 0.98 |
*
Significant difference.
C group, chemotherapy group; I group, immune checkpoint inhibitors‐containing group; pts, patients.