Table 2.
Characteristics of ICIs related SJS/TEN cases from FAERs database.
| All cases (n = 411) | SJS(n = 253) | TEN (n = 184) | |
|---|---|---|---|
| Reporter | |||
| Total data | 406 | 250 | 181 |
| Health-care professional | 314(77.3%) | 191(76.4%) | 141(77.9%) |
| Non-health-care professional | 92(22.7%) | 59(23.6%) | 40(22.1%) |
| Sex | |||
| Total data | 361 | 229 | 155 |
| Male | 212(58.7%) | 139(60.7%) | 88(56.8%) |
| Female | 149(41.3%) | 90(39.3%) | 67(43.2%) |
| Age | |||
| Total data | 305 | 190 | 132 |
| Median | 66years | 65years | 66years |
| Range | 32–89years | 32–87years | 36–89years |
| Indication | |||
| Total data | 358 | 217 | 161 |
| Lung cancer | 167(46.6%) | 101(46.5%) | 77(47.8%) |
| Melanoma | 62(17.3%) | 31(14.3%) | 32(19.9%) |
| Renal Cancer | 29(8.1%) | 15(6.9%) | 15(9.3%) |
| Lymphoma | 17(4.7%) | 7(3.2%) | 12(7.5%) |
| Head And Neck Cancer | 16(4.5%) | 15(6.9%) | 2(1.2%) |
| Other cancer/Unknown Indication | 67(18.7%) | 48(22.1%) | 23(14.3%) |
| Report countries | |||
| Total data | 409 | 251 | 184 |
| Japan,JP | 119(29.1%) | 94(37.5%) | 31(16.8%) |
| United States,US | 109(26.7%) | 75(29.9%) | 45(24.5%) |
| Germany,DE | 35(8.6%) | 13(5.2%) | 26(14.1%) |
| Canada, CA | 27(6.6%) | 7(2.8%) | 20(10.9%) |
| United Kingdom,GB | 27(6.6%) | 6(2.4%) | 22(11.9%) |
| Other countries | 92(22.5%) | 56(22.3%) | 40(21.7%) |
| Reporting year | |||
| Total data | 411 | 253 | 184 |
| 2020 | 132(32.1%) | 82(32.4%) | 61(33.2%) |
| 2019 | 119(28.9%) | 70(27.7%) | 58(31.5%) |
| 2018 | 68(16.5%) | 43(17%) | 26(14.1%) |
| 2017 | 51(12.4%) | 34(13.4%) | 20(10.9%) |
| 2016 | 26(6.3%) | 18(7.1%) | 10(5.4%) |
| 2015 | 9(2.2%) | 3(1.2%) | 6(3.3%) |
| 2014 | 1(0.2%) | 1(0.4%) | 0(0%) |
| 2013 | 4(1%) | 1(0.4%) | 3(1.6%) |
| 2012 | 0(0%) | 0(0%) | 0(0%) |
| 2011 | 1(0.2%) | 1(0.4%) | 0(0%) |
| Reaction Outcome | |||
| Total data | 305 | 176 | 146 |
| Recovered/resolved | 77(25.2%) | 56(31.8%) | 24(16.4%) |
| Recovering/resolving | 73(23.9%) | 50(28.4%) | 24(16.4%) |
| Not recovered/not resolved | 39(12.8%) | 33(18.7%) | 7(4.8%) |
| Recovered/resolved with sequelae | 3(1%) | 2(1.1%) | 1(0.7%) |
| Fatal | 113(37.0%) | 35(19.9%) | 90(61.6%) |
| Treatment modifications | |||
| Total data | 201 | 143 | 67 |
| Drug withdrawn | 196(97.5%) | 140(97.9%) | 65(97.0%) |
| Dose reduced | 0(0%) | 0(0%) | 0(0%) |
| Dose not changed | 5(2.5%) | 3(2.1%) | 2(3.0%) |
| Latency period | |||
| Total data | 190 | 130 | 70 |
| Median | 25.5 days | 21.5days | 32days |
| Range | 0-844 days | 0-844 days | 0-500 days |
| Within 3 weeks | 86(45.3%) | 65(50%) | 26(37.1%) |
| <24 h | 7(3.7%) | 6(46.2%) | 1(1.4%) |
| 1–7 days | 31(16.3%) | 23(17.7%) | 11(15.7%) |
| 8-30days | 73(38.4%) | 54(41.5%) | 22(31.4%) |
| 31-60days | 38(20%) | 17(13.1%) | 24(34.3%) |
| >61 days | 41(21.6%) | 30(23.1%) | 12(17.1%) |