Table 2.
AEs signal detection in patients who treated with pembrolizumab
| Adverse event | PRR | RRR | ROR | Event counts |
|---|---|---|---|---|
| immune-mediated hyperthyroidism | 621.976 | 156.244 | 622.315 | 3 |
| immune-mediated hypothyroidism | 552.868 | 151.509 | 556.103 | 32 |
| tumour pseudoprogression | 345.542 | 130.203 | 346.486 | 15 |
| immune-mediated adrenal insufficiency | 345.542 | 130.203 | 346.171 | 10 |
| immune-mediated pneumonitis | 310.988 | 124.995 | 311.837 | 15 |
| immune-mediated thyroiditis | 248.79 | 113.632 | 249.061 | 6 |
| immune-mediated renal disorder | 233.241 | 110.29 | 233.622 | 9 |
| immune-mediated hepatic disorder | 225.619 | 108.564 | 227.143 | 37 |
| immune-mediated dermatitis | 190.048 | 99.634 | 190.428 | 11 |
| immune-mediated cholangitis | 186.593 | 98.68 | 186.898 | 9 |
| immune-mediated encephalitis | 168.452 | 93.387 | 168.849 | 13 |
| krebs lungen-6 increased | 165.86 | 92.589 | 165.98 | 4 |
| immune-mediated myocarditis | 160.087 | 90.77 | 161.874 | 61 |
| adrenocorticotropic hormone deficiency | 142.536 | 84.873 | 142.82 | 11 |
| immune-mediated nephritis | 138.217 | 83.33 | 138.367 | 6 |
| tumour hyperprogression | 130.942 | 80.642 | 131.227 | 12 |
| immune-mediated adverse reaction | 117.671 | 75.428 | 118.119 | 21 |
| hypothalamo-pituitary disorder | 103.663 | 69.442 | 103.775 | 6 |
| immune-mediated enterocolitis | 99.516 | 67.565 | 100.385 | 48 |
| immune-mediated myasthenia gravis | 98.726 | 67.202 | 98.905 | 10 |
| immune-mediated pancreatitis | 88.854 | 62.498 | 88.902 | 3 |
| vitiligo | 77.747 | 56.816 | 77.873 | 9 |
| limbic encephalitis | 77.747 | 56.816 | 77.831 | 6 |
| autoimmune myositis | 75.391 | 55.553 | 75.445 | 4 |
| immune-mediated lung disease | 74.424 | 55.029 | 74.801 | 28 |
| eastern cooperative oncology group performance status worsened | 72.214 | 53.817 | 72.619 | 31 |
| immune-mediated hepatitis | 70.735 | 52.995 | 71.105 | 29 |
| blood corticotrophin decreased | 69.108 | 52.081 | 69.171 | 5 |
| immune-mediated hypophysitis | 69.108 | 52.081 | 69.146 | 3 |
| paraneoplastic neurological syndrome | 69.108 | 52.081 | 69.146 | 3 |
| immune-mediated myositis | 57.476 | 45.218 | 57.766 | 28 |
| cortisol decreased | 56.543 | 44.641 | 56.574 | 3 |
| myasthenia gravis | 54.853 | 43.586 | 55.438 | 59 |
| autoimmune colitis | 54.559 | 43.401 | 54.608 | 5 |
| autoimmune myocarditis | 54.559 | 43.401 | 54.608 | 5 |
| fulminant type 1 diabetes mellitus | 54.085 | 43.102 | 54.143 | 6 |
| cholangitis sclerosing | 52.487 | 42.086 | 52.676 | 20 |
| pericarditis malignant | 48.782 | 39.681 | 48.817 | 4 |
| urogenital fistula | 47.844 | 39.061 | 47.87 | 3 |
| encephalitis autoimmune | 40.454 | 34.012 | 40.511 | 8 |
| thrombophlebitis migrans | 39.491 | 33.332 | 39.547 | 8 |
| malignant neoplasm progression | 24.405 | 21.94 | 39.038 | 2112 |
| tumour associated fever | 38.873 | 32.893 | 38.915 | 6 |
| iga nephropathy | 36.587 | 31.249 | 36.606 | 3 |
| hypopituitarism | 33.62 | 29.069 | 33.692 | 12 |
| myasthenia gravis crisis | 33.172 | 28.735 | 33.196 | 4 |
| myasthenic syndrome | 31.55 | 27.515 | 31.589 | 7 |
| trousseau’s syndrome | 31.099 | 27.173 | 31.132 | 6 |
| myositis | 29.885 | 26.246 | 30.14 | 48 |
| pericardial effusion malignant | 29.618 | 26.041 | 29.634 | 3 |
Abbreviations: PRR: Proportional Reporting Ratio; RRR: Relative Reporting Ratio; ROR: Reporting Odds Ratio