Table 3.
Cumulative Rates of Individual irAEs.
| Month 1 % (95% CI) | Month 3 % (95% CI) | Month 6 % (95% CI) | Month 9 % (95% CI) | |
|---|---|---|---|---|
| Hematologic | ||||
| Anemia | 1.79% (1.38, 2.32) | 4.41% (3.73, 5.21) | 7.79% (6.78, 8.94) | 9.93% (8.62, 11.42) |
| Thrombocytopenia | 0.51% (0.31, 0.83) | 0.96% (0.66, 1.37) | 1.63% (1.20, 2.23) | 1.91% (1.40, 2.62) |
| Leukopenia | 0.41% (0.24, 0.71) | 1.02% (0.71, 1.45) | 1.76% (1.31, 2.36) | 2.48% (1.84, 3.35) |
| Pulmonary | ||||
| Pneumonitis | 2.49% (2.00, 3.10) | 5.90% (5.11, 6.81) | 10.55% (9.38, 11.85) | 14.26% (12.67, 16.02) |
| Endocrine | ||||
| Hypothyroidism | 0.80 (0.54, 1.18) | 2.61% (2.09, 3.25) | 6.79% (5.79, 7.95) | 10.16% (8.68, 11.87) |
| Hyperthyroidism | 0.10% (0.03, 0.30) | 1.01% (0.70, 1.45) | 1.48% (1.08, 2.04) | 1.91% (1.37, 2.65) |
| Hypophysitis/PGA | 0.57% (0.36, 0.91) | 1.55% (1.16, 2.06) | 2.86% (2.25, 3.63) | 3.56% (2.79, 4.52) |
| Hypo/Hyperparathyroid | 0.00% | 0.07% (0.02, 0.27) | 0.07% (0.02, 0.27) | 0.07% (0.02, 0.27) |
| Diabetes Type I | 0.16% (0.07, 0.38) | 0.44% (0.26, 0.76) | 1.08% (0.72, 1.63) | 1.49% (1.00, 2.23) |
| Dysfunctional Uterine Bleeding/Infertility | 0.06% (0.02, 0.26) | 0.16% (0.07, 0.39) | 0.25% (0.12, 0.52) | 0.25% (0.12, 0.52) |
| Renal | ||||
| AKI | 1.09% (0.78, 1.52) | 3.07% (2.51, 3.76) | 5.24% (4.41, 6.23) | 7.33% (6.18, 8.69) |
| Neurologic | ||||
| Neuritis | 0.54% (0.34, 0.87) | 1.27% (0.93, 1.75) | 2.04% (1.55, 2.69) | 2.46% (1.85, 3.28) |
| Meningitis | 0.00% | 0.16% (0.07, 0.39) | 0.21% (0.09, 0.48) | 0.49% (0.23, 1.01) |
| Encephalitis/Myelitis/Encephalomyelitis | 0.13% (0.05, 0.34) | 0.47% (0.28, 0.79) | 0.94% (0.62, 1.44) | 1.12% (0.74, 1.71) |
| Hepatic | ||||
| Hepatitis | 0.58% (0.36, 0.91) | 1.45% (1.08, 1.95) | 3.05% (2.41, 3.87) | 3.73% (2.93, 4.75) |
| Gastrointestional | ||||
| Colitis | 0.26% (0.13, 0.51) | 1.30% (0.95, 1.79) | 2.49% (1.93, 3.22) | 3.24% (2.51, 4.17) |
| Pancreatitis | 0.06% (0.02, 0.25) | 0.24% (0.11, 0.51) | 0.45% (0.26, 0.80) | 0.53% (0.30, 0.94) |
| Mucositis | 0.00% | 0.07% (0.02, 0.27) | 0.39% (0.20, 0.76) | 0.51% (0.26, 1.01) |
| Cardiac | ||||
| Arrhythmia | 1.47% (1.10, 1.95) | 3.22% (2.65, 3.92) | 5.98% (5.10, 7.02) | 9.07% (7.73, 10.61) |
| Acute MI | 0.51% (0.31, 0.83) | 0.99% (0.70, 1.42) | 2.07% (1.56, 2.76) | 2.85% (2.15, 3.78) |
| Myocarditis | 0.16% (0.07, 0.38) | 0.37% (0.21, 0.67) | 0.60% (0.36, 1.02) | 0.89% (0.53, 1.49) |
| Pericarditis | 0.19% (0.09, 0.42) | 0.67% (0.44, 1.04) | 1.56% (1.11, 2.19) | 1.65% (1.18, 2.31) |
| Cardiomyopathy | 0.22% (0.11, 0.47) | 0.33% (0.18, 0.62) | 0.85% (0.53, 1.37) | 1.02% (0.65, 1.61) |
| Skin | ||||
| Vitiligo | 0.06% (0.02, 0.26) | 0.13% (0.05, 0.36) | 0.13% (0.05, 0.36) | 0.22% (0.08, 0.57) |