Demographics, clinical characteristics and age-based differences in patients with AEs following ICI administration reported in the FAERS database
| Clinical characteristics . | Patients aged 18–64 (%) . | Patients aged 65–74 (%) . | Patients aged 75–84 (%) . | Patients aged 85+ (%) . | ||||
|---|---|---|---|---|---|---|---|---|
| irAE cases n = 20,021 . | Non- irAE cases n = 19,933 . | irAE cases n = 17,225 . | Non- irAE cases n = 14,718 . | irAE cases n = 9138 . | Non- irAE cases n = 7666 . | irAE cases n = 1129 . | Non- irAE cases n = 1160 . | |
| Sex | ||||||||
| Male | 11 374 (57.37%) | 11 414 (58.56%) | 11 570 (67.95%) | 9769 (67.96%) | 6124 (68.01%) | 5065 (68.00%) | 716 (64.57%) | 713 (64.56%) |
| Female | 8451 (42.63%) | 8076 (41.44%) | 5464 (32.05%) | 4606 (32.04%) | 2882 (31.99%) | 2391 (32.00%) | 393 (35.43%) | 403 (35.44%) |
| Missing | 196 | 443 | 191 | 343 | 132 | 210 | 20 | 44 |
| Age (Median, q1–q3, % data included) | (56, 50–61, 100%) | (56, 49–61 (100%) | (70, 67–72, 100%) | (69, 67–72 (100%) | (78, 76–80, 100%) | (78, 76–80 (100%) | (86, 85–88, 100%) | (87, 85–89) (100%) |
| Time to onset (Median, q1–q3, % data included) | (41, 14–105) (57.99%) | (44, 14–124) (52.74%) | (42, 14–108) (59.64%) | (46, 14–129 (54.48%) | (41, 14–107) (58.35%) | (48, 14–131 (51.41%) | (44.5, 18–123.5) (50.84%) | (43, 11–144.25 (40.34%) |
| Reporter type | ||||||||
| Healthcare worker | 16 896 (84.83%) | 14 455 (73.52%) | 14 297 (83.67%) | 10 781 (74.28%) | 7536 (83.23%) | 5658 (75.11%) | 914 (81.39%) | 786 (68.59%) |
| Consumer | 3019 (15.17%) | 5205 (26.48%) | 2812 (16.77%) | 3733 (25.72%) | 1526 (16.77%) | 1875 (24.89%) | 209 (18.61%) | 360 (31.41%) |
| Missing | 106 | 273 | 116 | 204 | 76 | 133 | 6 | 14 |
| Income level by country | ||||||||
| High income | 17 111 (91.95%) | 15 167 (84.76%) | 15 226 (94.73%) | 11 755 (89.46%) | 8267 (96.59%) | 6446 (92.98%) | 1057 (98.14%) | 1021 (94.28%) |
| Upper middle income | 1382 (7.43%) | 1969 (11.00%) | 776 (4.83%) | 1084 (8.25%) | 266 (3.11%) | 388 (5.60%) | 20 (1.86%) | 51 (4.71%) |
| Lower to middle income | 115 (0.62%) | 758 (4.24%) | 71 (0.44%) | 301 (2.29%) | 26 (0.30%) | 99 (1.43%) | 0 (0%) | 11 (1.02%) |
| Missing | 1413 | 2039 | 1152 | 1578 | 579 | 733 | 52 | 77 |
| Received year | ||||||||
| 2023 | 2738 (13.67%) | 2338 (11.73%) | 2449 (14.22%) | 1758 (11.94%) | 1354 (14.82%) | 991 (12.94%) | 160 (14.17%) | 144 (12.41%) |
| 2022 | 3085 (15.40%) | 3355 (16.83%) | 2876 (16.7%) | 2548 (17.31%) | 1558 (17.05%) | 1340 (17.49%) | 189 (16.74%) | 220 (18.97%) |
| 2021 | 2977 (14.86%) | 2880 (14.45%) | 2676 (15.54%) | 2199 (14.94%) | 1454 (15.91%) | 1160 (15.13%) | 174 (15.41%) | 163 (14.05%) |
| 2020 | 2610 (13.03%) | 2411 (12.1%) | 2258 (13.11%) | 1814 (12.33%) | 1202 (13.15%) | 962 (12.55%) | 159 (14.08%) | 161 (13.88%) |
| 2019 | 2840 (14.18%) | 2683 (13.46%) | 2479 (14.39%) | 2031 (13.8%) | 1299 (14.22%) | 1130 (14.74%) | 150 (13.29%) | 154 (13.28%) |
| 2018 | 2438 (12.17%) | 2406 (12.07%) | 2074 (12.04%) | 1811 (12.3%) | 1049 (11.48%) | 921 (12.02%) | 149 (13.2%) | 133 (11.47%) |
| 2017 | 1632 (8.15%) | 1778 (8.92%) | 1267 (7.36%) | 1242 (8.44%) | 648 (7.09%) | 577 (7.54%) | 73 (6.47%) | 91 (7.84%) |
| 2016 | 1013 (5.06%) | 1260 (6.32%) | 676 (3.92%) | 862 (5.86%) | 371 (4.06%) | 408 (5.32%) | 48 (4.25%) | 74 (6.38%) |
| 2015 | 687 (3.43%) | 820 (4.12%) | 464 (2.69%) | 452 (3.08%) | 202 (2.21%) | 173 (2.27%) | 27 (2.39%) | 20 (1.72%) |
| Missing | 1 | 2 | 6 | 1 | 1 | 4 | 0 | 0 |
| Indication organ/system | ||||||||
| Head and neck | 589 (3.07%) | 997 (5.46%) | 441 (2.67%) | 568 (4.19%) | 211 (2.41%) | 239 (3.39%) | 26 (2.43%) | 43 (3.22%) |
| Lung | 5770 (30.07%) | 5511 (30.20%) | 6722 (40.66%) | 5530 (40.83%) | 3236 (37.03%) | 2596 (36.88%) | 287 (26.85%) | 299 (29.34%) |
| Urogenital | 2702 (14.08%) | 2308 (12.65%) | 2831 (17.12%) | 2101 (15.51%) | 1614 (18.43%) | 1248 (17.73%) | 197 (18.43%) | 169 (16.58%) |
| Gynecologic | 798 (4.16%) | 757 (4.15%) | 478 (2.89%) | 392 (2.89%) | 168 (1.92%) | 173 (2.46%) | 7 (0.65%) | 16 (1.57%) |
| Breast | 965 (5.03%) | 799 (4.38%) | 251 (1.52%) | 170 (1.26%) | 80 (0.92%) | 71 (1.01%) | 7 (0.65%) | 6 (0.59%) |
| Haematopoietic and lymphoid | 455 (2.37%) | 522 (2.86%) | 242 (1.46%) | 261 (1.93%) | 133 (1.52%) | 165 (2.34%) | 18 (1.68%) | 26 (2.55%) |
| Gastrointestinal | 1143 (5.96%) | 1614 (8.84%) | 979 (5.92%) | 1031 (7.61%) | 528 (6.04%) | 514 (7.3%) | 60 (5.61%) | 63 (6.18%) |
| Other indications | 682 (3.55%) | 801 (4.39%) | 441 (2.67%) | 428 (3.16%) | 207 (2.37%) | 209 (2.97%) | 26 (2.43%) | 35 (3.43%) |
| Hepatopancreatobiliary | 759 (3.96%) | 1044 (5.72%) | 735 (4.45%) | 851 (6.28%) | 435 (4.98%) | 444 (6.31%) | 69 (6.45%) | 71 (6.97%) |
| Skin | 4917 (25.63%) | 3057 (16.75%) | 3082 (18.64%) | 1738 (12.83%) | 1904 (21.79%) | 1128 (16.02%) | 352 (32.93%) | 244 (23.95%) |
| Other thoracic (cardiac, mesothelioma, thymus) | 123 (0.64%) | 159 (0.87%) | 223 (1.35%) | 212 (1.57%) | 171 (1.96%) | 160 (2.27%) | 13 (1.22%) | 21 (2.06%) |
| Musculoskeletal | 120 (0.63%) | 259 (1.42%) | 45 (0.27%) | 101 (0.75%) | 32 (0.37%) | 42 (0.60%) | 4 (0.37%) | 16 (1.57%) |
| CNS | 110 (0.57%) | 318 (1.74%) | 32 (0.19%) | 110 (0.81%) | 6 (0.07%) | 31 (0.44%) | 1 (0.09%) | 2 (0.20%) |
| Endocrine | 54 (0.28%) | 103 (0.56%) | 32 (0.19%) | 51 (0.38%) | 13 (0.15%) | 20 (0.28%) | 2 (0.19%) | 8 (0.79%) |
| Unspecified or missing | 834 | 1684 | 691 | 1174 | 400 | 626 | 60 | 141 |
| Dechallenge | ||||||||
| Applied | 7605 (81.13%) | 3661 (43.77%) | 7067 (79.51%) | 3275 (50.24%) | 3715 (77.48%) | 1661 (47.88%) | 436 (73.90%) | 200 (36.63%) |
| Positive | 6457 (84.90%) | 2907 (79.40%) | 6001 (84.92%) | 2550 (77.86%) | 3118 (83.93%) | 1279 (77.00%) | 357 (81.88%) | 146 (73.00%) |
| Negative | 1148 (15.10%) | 754 (20.60%) | 1066 (15.08%) | 725 (22.14%) | 597 (16.07%) | 382 (23.00%) | 79 (18.12%) | 54 (27.00%) |
| Not applied | 1748 (18.87%) | 4705 (56.23%) | 1820 (20.49%) | 3245 (49.76%) | 1079 (22.52%) | 1808 (52.12%) | 154 (26.1%) | 346 (63.37%) |
| Missing | 10 668 | 11 567 | 8338 | 8198 | 4344 | 4197 | 539 | 614 |
| Rechallenge | ||||||||
| Applied | 338 (33.67%) | 233 (24.84%) | 310 (34.83%) | 187 (31.22%) | 148 (36.36%) | 95 (30.84%) | 16 (22.54%) | 17 (34.00%) |
| Positive | 131 (38.76%) | 75 (32.19%) | 115 (37.10%) | 68 (36.36%) | 50 (33.78%) | 29 (33.78%) | 7 (43.75%) | 4 (23.53%) |
| Negative | 207 (61.24%) | 158 (67.81%) | 195 (62.90%) | 119 (63.64%) | 98 (66.22%) | 66 (66.22%) | 9 (56.25%) | 13 (76.47%) |
| Not applied | 666 (66.33%) | 705 (75.16%) | 580 (65.17%) | 412 (68.78%) | 259 (63.64%) | 213 (69.16%) | 55 (77.46%) | 33 (66.00%) |
| Missing | 19 017 | 18 995 | 16 335 | 14 119 | 8731 | 7358 | 1058 | 1110 |
| Outcomes | ||||||||
| Nonserious outcome | 794 (3.97%) | 1739 (8.72%) | 658 (3.82%) | 1089 (7.4%) | 383 (4.19%) | 637 (8.31%) | 89 (7.88%) | 174 (15%) |
| Serious outcome | 19 227 (96.03%) | 18 194 (91.28%) | 16 567 (96.18%) | 13 629 (92.6%) | 8755 (95.81%) | 7029 (91.69%) | 1040 (92.12%) | 986 (85%) |
| Death | 2951 (14.74%) | 6768 (33.95%) | 3202 (18.59%) | 5075 (34.48%) | 2105 (23.04%) | 2743 (35.78%) | 249 (22.05%) | 466 (40.17%) |
| Hospitalisation | 11 649 (58.18%) | 8471 (42.5%) | 10 378 (60.25%) | 6577 (44.69%) | 5473 (59.89%) | 3236 (42.21%) | 613 (54.3%) | 374 (32.24%) |
| Life-threatening | 2039 (10.18%) | 1001 (5.02%) | 1926 (11.18%) | 771 (5.24%) | 1041 (11.39%) | 395 (5.15%) | 97 (8.59%) | 55 (4.74%) |
| Disability | 632 (3.16%) | 328 (1.65%) | 584 (3.39%) | 293 (1.99%) | 359 (3.93%) | 147 (1.92%) | 40 (3.54%) | 20 (1.72%) |
| Required intervention to prevent permanent impairment/damage | 35 (0.17%) | 10 (0.05%) | 48 (0.28%) | 14 (0.1%) | 31 (0.34%) | 9 (0.12%) | 5 (0.44%) | 2 (0.17%) |
| Other serious | 15 095 (75.4%) | 12 210 (61.26%) | 13 004 (75.49%) | 8952 (60.82%) | 6924 (75.77%) | 4678 (61.02%) | 806 (71.39%) | 695 (59.91%) |
| Dosage (Median, q1–q3) (% data included) | ||||||||
| Cumulative total dosage | (662.58, 222.6–1781.61) (12.34%) | (720, 240–2280 (8.89%) | (600, 200–1600) (15%) | (720, 240–2160 (10.91%) | (600, 200–1500) (15.08%) | (600, 216–1800 (10.66%) | (400, 200–1500) (13.91%) | (830, 240–1710 (8.62%) |
| Cumulative total dosage, per kg | (10, 3.51–25) (9.9%) | (9.99, 3.7–27) (6.56%) | (9.38, 3.7–25) (12.23%) | [4–30] (7.74%) | (9.8, 3.98–23.53) (11.85%) | (9.84, 3.92–24.89) (7.77%) | (7.41, 3.92–26.44) (9.65%) | (11.94, 5–30) (5.6%) |
| Total dosage, per shot | (240, 200–710) (55.48%) | (240 200–740) (59.9%) | (240 200–560) (59.58%) | (240 200–840) (60.32%) | (225 200–480) (58.56%) | (240 200–615) (59.31%) | (200 200–400) (55.71%) | (240, 200–480) (54.31%) |
| Total dosage, per shot, per kg | (3, 2.86–9.16) (45.95%) | (3.08, 3–10) (37.95%) | (3.2, 2.99–9.77) (46.8%) | (3.45, 3–10) (39.4%) | (3.29, 3–9.23) (44.97%) | (3.8, 3–10 (36.15%) | (3.12, 2.84–6) (39.06%) | (3.57, 2.99–10 (27.84%) |
| Treatment regimen | ||||||||
| No additional chemotherapy | 16 126 (80.55%) | 17 131 (85.94%) | 13 833 (80.31%) | 12 542 (85.22%) | 7838 (85.77%) | 6807 (88.79%) | 1052 (93.18%) | 1102 (95%) |
| Additional chemotherapy | 3895 (19.45%) | 2802 (14.06%) | 3392 (19.69%) | 2176 (14.78%) | 1300 (14.23%) | 859 (11.21%) | 77 (6.82%) | 58 (5%) |
| No additional targeted therapy | 16 923 (84.53%) | 17 420 (87.39%) | 14 630 (84.93%) | 12 934 (87.88%) | 8002 (87.57%) | 6821 (88.98%) | 1018 (90.17%) | 1047 (90.26%) |
| Additional targeted therapy | 3098 (15.47%) | 2513 (12.61%) | 2595 (15.07%) | 1784 (12.12%) | 1136 (12.43%) | 845 (11.02%) | 111 (9.83%) | 113 (9.74%) |
| No polytherapy | 15 040 (75.12%) | 16 536 (82.96%) | 13 680 (79.42%) | 12 441 (84.53%) | 7542 (82.53%) | 6659 (86.86%) | 1004 (88.93%) | 1028 (88.62%) |
| Polytherapy | 4981 (24.88%) | 3397 (17.04%) | 3545 (20.58%) | 2277 (15.47%) | 1596 (17.47%) | 1007 (13.14%) | 125 (11.07%) | 132 (11.38%) |
| Number of different immunotherapy agents used | ||||||||
| Monotherapy | 15 040 (75.12%) | 16 536 (82.96%) | 13 680 (79.42%) | 12 441 (84.53%) | 7542 (82.53%) | 6659 (86.86%) | 1004 (88.93%) | 1028 (88.62%) |
| Anti-PD-1 | 10 581 (52.85%) | 11 642 (58.41%) | 9888 (57.4%) | 8444 (57.37%) | 5547 (60.7%) | 4712 (61.47%) | 796 (70.5%) | 808 (69.66%) |
| Nivolumab | 5650 (28.22%) | 7445 (37.35%) | 5116 (29.7%) | 5222 (35.48%) | 2705 (29.6%) | 2637 (34.4%) | 330 (29.23%) | 419 (36.12%) |
| Pembrolizumab | 4859 (24.27%) | 4116 (20.65%) | 4700 (27.29%) | 3151 (21.41%) | 2794 (30.58%) | 2038 (26.58%) | 441 (39.06%) | 360 (31.03%) |
| Cemiplimab | 52 (0.26%) | 49 (0.25%) | 57 (0.33%) | 43 (0.29%) | 45 (0.49%) | 34 (0.44%) | 23 (2.04%) | 29 (2.5%) |
| Dostarlimab | 20 (0.1%) | 32 (0.16%) | 15 (0.09%) | 28 (0.19%) | 3 (0.03%) | 3 (0.04%) | 2 (0.18%) | 0 (0%) |
| Anti-PD-L1 | 3551 (17.74%) | 4322 (21.68%) | 3251 (18.87%) | 3667 (24.92%) | 1709 (18.7%) | 1788 (23.32%) | 174 (15.41%) | 203 (17.5%) |
| Atezolizumab | 2653 (13.25%) | 2999 (15.05%) | 2289 (13.29%) | 2315 (15.73%) | 1161 (12.71%) | 1075 (14.02%) | 124 (10.98%) | 122 (10.52%) |
| Durvalumab | 715 (3.57%) | 1063 (5.33%) | 755 (4.38%) | 1095 (7.44%) | 409 (4.48%) | 524 (6.84%) | 23 (2.04%) | 46 (3.97%) |
| Avelumab | 183 (0.91%) | 260 (1.3%) | 207 (1.2%) | 257 (1.75%) | 139 (1.52%) | 189 (2.47%) | 27 (2.39%) | 35 (3.02%) |
| Anti-CTLA-4 | 908 (4.54%) | 572 (2.87%) | 541 (3.14%) | 330 (2.24%) | 286 (3.13%) | 159 (2.07%) | 34 (3.01%) | 17 (1.47%) |
| Ipilimumab | 906 (4.53%) | 569 (2.85%) | 540 (3.13%) | 329 (2.24%) | 285 (3.12%) | 159 (2.07%) | 34 (3.01%) | 17 (1.47%) |
| Tremelimumab | 2 (0.01%) | 3 (0.02%) | 1 (0.01%) | 1 (0.01%) | 1 (0.01%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dual therapy | 4891 (24.43%) | 3363 (16.87%) | 3472 (20.16%) | 2247 (15.27%) | 1573 (17.21%) | 989 (12.9%) | 123 (10.89%) | 131 (11.29%) |
| Nivolumab + ipilimumab | 4441 (22.18%) | 3023 (15.17%) | 3113 (18.07%) | 1978 (13.44%) | 1411 (15.44%) | 884 (11.53%) | 115 (10.19%) | 118 (10.17%) |
| Nivolumab + pembrolizumab | 36 (0.18%) | 15 (0.08%) | 35 (0.2%) | 16 (0.11%) | 17 (0.19%) | 6 (0.08%) | 1 (0.09%) | 2 (0.17%) |
| Pembrolizumab + ipilimumab | 120 (0.6%) | 53 (0.27%) | 71 (0.41%) | 16 (0.11%) | 31 (0.34%) | 13 (0.17%) | 2 (0.18%) | 2 (0.17%) |
| Nivolumab + relatlimab | 35 (0.17%) | 73 (0.37%) | 39 (0.23%) | 51 (0.35%) | 23 (0.25%) | 28 (0.37%) | 2 (0.18%) | 7 (0.6%) |
| Durvalumab + tremelimumab | 228 (1.14%) | 173 (0.87%) | 192 (1.11%) | 159 (1.08%) | 78 (0.85%) | 44 (0.57%) | 3 (0.27%) | 1 (0.09%) |
| Triple therapy or more | 90 (0.45%) | 30 (0.15%) | 73 (0.42%) | 30 (0.2%) | 23 (0.25%) | 18 (0.23%) | 2 (0.18%) | 1 (0.09%) |
| Nivolumab + pembrolizumab + atezolizumab | 0 (0%) | 14 (0.07%) | 0 (0%) | 21 (0.14%) | 2 (0.02%) | 5 (0.07%) | 0 (0%) | 1 (0.09%) |
| Nivolumab + ipilimumab + relatlimab | 12 (0.06%) | 9 (0.05%) | 16 (0.09%) | 5 (0.03%) | 4 (0.04%) | 12 (0.16%) | 0 (0%) | 0 (0%) |
| Number of different chemotherapy agents used | ||||||||
| None | 16 126 (80.55%) | 17 131 (85.94%) | 13 833 (80.31%) | 12 542 (85.22%) | 7838 (85.77%) | 6807 (88.79%) | 1052 (93.18%) | 1102 (95%) |
| One | 875 (4.37%) | 787 (3.95%) | 682 (3.96%) | 509 (3.46%) | 287 (3.14%) | 226 (2.95%) | 28 (2.48%) | 21 (1.81%) |
| Two or more | 3020 (15.08%) | 2015 (10.11%) | 2710 (15.73%) | 1667 (11.33%) | 1013 (11.09%) | 633 (8.26%) | 49 (4.34%) | 37 (3.19%) |
| Number of different targeted therapy agents used | ||||||||
| None | 16 923 (84.53%) | 17 420 (87.39%) | 14 630 (84.93%) | 12 934 (87.88%) | 8002 (87.57%) | 6821 (88.98%) | 1018 (90.17%) | 1047 (90.26%) |
| One | 2632 (13.15%) | 2228 (11.18%) | 2389 (13.87%) | 1645 (11.18%) | 1053 (11.52%) | 799 (10.42%) | 105 (9.3%) | 109 (9.4%) |
| Two or more | 466 (2.33%) | 285 (1.43%) | 206 (1.2%) | 139 (0.94%) | 83 (0.91%) | 46 (0.6%) | 6 (0.53%) | 4 (0.34%) |
| Clinical characteristics . | Patients aged 18–64 (%) . | Patients aged 65–74 (%) . | Patients aged 75–84 (%) . | Patients aged 85+ (%) . | ||||
|---|---|---|---|---|---|---|---|---|
| irAE cases n = 20,021 . | Non- irAE cases n = 19,933 . | irAE cases n = 17,225 . | Non- irAE cases n = 14,718 . | irAE cases n = 9138 . | Non- irAE cases n = 7666 . | irAE cases n = 1129 . | Non- irAE cases n = 1160 . | |
| Sex | ||||||||
| Male | 11 374 (57.37%) | 11 414 (58.56%) | 11 570 (67.95%) | 9769 (67.96%) | 6124 (68.01%) | 5065 (68.00%) | 716 (64.57%) | 713 (64.56%) |
| Female | 8451 (42.63%) | 8076 (41.44%) | 5464 (32.05%) | 4606 (32.04%) | 2882 (31.99%) | 2391 (32.00%) | 393 (35.43%) | 403 (35.44%) |
| Missing | 196 | 443 | 191 | 343 | 132 | 210 | 20 | 44 |
| Age (Median, q1–q3, % data included) | (56, 50–61, 100%) | (56, 49–61 (100%) | (70, 67–72, 100%) | (69, 67–72 (100%) | (78, 76–80, 100%) | (78, 76–80 (100%) | (86, 85–88, 100%) | (87, 85–89) (100%) |
| Time to onset (Median, q1–q3, % data included) | (41, 14–105) (57.99%) | (44, 14–124) (52.74%) | (42, 14–108) (59.64%) | (46, 14–129 (54.48%) | (41, 14–107) (58.35%) | (48, 14–131 (51.41%) | (44.5, 18–123.5) (50.84%) | (43, 11–144.25 (40.34%) |
| Reporter type | ||||||||
| Healthcare worker | 16 896 (84.83%) | 14 455 (73.52%) | 14 297 (83.67%) | 10 781 (74.28%) | 7536 (83.23%) | 5658 (75.11%) | 914 (81.39%) | 786 (68.59%) |
| Consumer | 3019 (15.17%) | 5205 (26.48%) | 2812 (16.77%) | 3733 (25.72%) | 1526 (16.77%) | 1875 (24.89%) | 209 (18.61%) | 360 (31.41%) |
| Missing | 106 | 273 | 116 | 204 | 76 | 133 | 6 | 14 |
| Income level by country | ||||||||
| High income | 17 111 (91.95%) | 15 167 (84.76%) | 15 226 (94.73%) | 11 755 (89.46%) | 8267 (96.59%) | 6446 (92.98%) | 1057 (98.14%) | 1021 (94.28%) |
| Upper middle income | 1382 (7.43%) | 1969 (11.00%) | 776 (4.83%) | 1084 (8.25%) | 266 (3.11%) | 388 (5.60%) | 20 (1.86%) | 51 (4.71%) |
| Lower to middle income | 115 (0.62%) | 758 (4.24%) | 71 (0.44%) | 301 (2.29%) | 26 (0.30%) | 99 (1.43%) | 0 (0%) | 11 (1.02%) |
| Missing | 1413 | 2039 | 1152 | 1578 | 579 | 733 | 52 | 77 |
| Received year | ||||||||
| 2023 | 2738 (13.67%) | 2338 (11.73%) | 2449 (14.22%) | 1758 (11.94%) | 1354 (14.82%) | 991 (12.94%) | 160 (14.17%) | 144 (12.41%) |
| 2022 | 3085 (15.40%) | 3355 (16.83%) | 2876 (16.7%) | 2548 (17.31%) | 1558 (17.05%) | 1340 (17.49%) | 189 (16.74%) | 220 (18.97%) |
| 2021 | 2977 (14.86%) | 2880 (14.45%) | 2676 (15.54%) | 2199 (14.94%) | 1454 (15.91%) | 1160 (15.13%) | 174 (15.41%) | 163 (14.05%) |
| 2020 | 2610 (13.03%) | 2411 (12.1%) | 2258 (13.11%) | 1814 (12.33%) | 1202 (13.15%) | 962 (12.55%) | 159 (14.08%) | 161 (13.88%) |
| 2019 | 2840 (14.18%) | 2683 (13.46%) | 2479 (14.39%) | 2031 (13.8%) | 1299 (14.22%) | 1130 (14.74%) | 150 (13.29%) | 154 (13.28%) |
| 2018 | 2438 (12.17%) | 2406 (12.07%) | 2074 (12.04%) | 1811 (12.3%) | 1049 (11.48%) | 921 (12.02%) | 149 (13.2%) | 133 (11.47%) |
| 2017 | 1632 (8.15%) | 1778 (8.92%) | 1267 (7.36%) | 1242 (8.44%) | 648 (7.09%) | 577 (7.54%) | 73 (6.47%) | 91 (7.84%) |
| 2016 | 1013 (5.06%) | 1260 (6.32%) | 676 (3.92%) | 862 (5.86%) | 371 (4.06%) | 408 (5.32%) | 48 (4.25%) | 74 (6.38%) |
| 2015 | 687 (3.43%) | 820 (4.12%) | 464 (2.69%) | 452 (3.08%) | 202 (2.21%) | 173 (2.27%) | 27 (2.39%) | 20 (1.72%) |
| Missing | 1 | 2 | 6 | 1 | 1 | 4 | 0 | 0 |
| Indication organ/system | ||||||||
| Head and neck | 589 (3.07%) | 997 (5.46%) | 441 (2.67%) | 568 (4.19%) | 211 (2.41%) | 239 (3.39%) | 26 (2.43%) | 43 (3.22%) |
| Lung | 5770 (30.07%) | 5511 (30.20%) | 6722 (40.66%) | 5530 (40.83%) | 3236 (37.03%) | 2596 (36.88%) | 287 (26.85%) | 299 (29.34%) |
| Urogenital | 2702 (14.08%) | 2308 (12.65%) | 2831 (17.12%) | 2101 (15.51%) | 1614 (18.43%) | 1248 (17.73%) | 197 (18.43%) | 169 (16.58%) |
| Gynecologic | 798 (4.16%) | 757 (4.15%) | 478 (2.89%) | 392 (2.89%) | 168 (1.92%) | 173 (2.46%) | 7 (0.65%) | 16 (1.57%) |
| Breast | 965 (5.03%) | 799 (4.38%) | 251 (1.52%) | 170 (1.26%) | 80 (0.92%) | 71 (1.01%) | 7 (0.65%) | 6 (0.59%) |
| Haematopoietic and lymphoid | 455 (2.37%) | 522 (2.86%) | 242 (1.46%) | 261 (1.93%) | 133 (1.52%) | 165 (2.34%) | 18 (1.68%) | 26 (2.55%) |
| Gastrointestinal | 1143 (5.96%) | 1614 (8.84%) | 979 (5.92%) | 1031 (7.61%) | 528 (6.04%) | 514 (7.3%) | 60 (5.61%) | 63 (6.18%) |
| Other indications | 682 (3.55%) | 801 (4.39%) | 441 (2.67%) | 428 (3.16%) | 207 (2.37%) | 209 (2.97%) | 26 (2.43%) | 35 (3.43%) |
| Hepatopancreatobiliary | 759 (3.96%) | 1044 (5.72%) | 735 (4.45%) | 851 (6.28%) | 435 (4.98%) | 444 (6.31%) | 69 (6.45%) | 71 (6.97%) |
| Skin | 4917 (25.63%) | 3057 (16.75%) | 3082 (18.64%) | 1738 (12.83%) | 1904 (21.79%) | 1128 (16.02%) | 352 (32.93%) | 244 (23.95%) |
| Other thoracic (cardiac, mesothelioma, thymus) | 123 (0.64%) | 159 (0.87%) | 223 (1.35%) | 212 (1.57%) | 171 (1.96%) | 160 (2.27%) | 13 (1.22%) | 21 (2.06%) |
| Musculoskeletal | 120 (0.63%) | 259 (1.42%) | 45 (0.27%) | 101 (0.75%) | 32 (0.37%) | 42 (0.60%) | 4 (0.37%) | 16 (1.57%) |
| CNS | 110 (0.57%) | 318 (1.74%) | 32 (0.19%) | 110 (0.81%) | 6 (0.07%) | 31 (0.44%) | 1 (0.09%) | 2 (0.20%) |
| Endocrine | 54 (0.28%) | 103 (0.56%) | 32 (0.19%) | 51 (0.38%) | 13 (0.15%) | 20 (0.28%) | 2 (0.19%) | 8 (0.79%) |
| Unspecified or missing | 834 | 1684 | 691 | 1174 | 400 | 626 | 60 | 141 |
| Dechallenge | ||||||||
| Applied | 7605 (81.13%) | 3661 (43.77%) | 7067 (79.51%) | 3275 (50.24%) | 3715 (77.48%) | 1661 (47.88%) | 436 (73.90%) | 200 (36.63%) |
| Positive | 6457 (84.90%) | 2907 (79.40%) | 6001 (84.92%) | 2550 (77.86%) | 3118 (83.93%) | 1279 (77.00%) | 357 (81.88%) | 146 (73.00%) |
| Negative | 1148 (15.10%) | 754 (20.60%) | 1066 (15.08%) | 725 (22.14%) | 597 (16.07%) | 382 (23.00%) | 79 (18.12%) | 54 (27.00%) |
| Not applied | 1748 (18.87%) | 4705 (56.23%) | 1820 (20.49%) | 3245 (49.76%) | 1079 (22.52%) | 1808 (52.12%) | 154 (26.1%) | 346 (63.37%) |
| Missing | 10 668 | 11 567 | 8338 | 8198 | 4344 | 4197 | 539 | 614 |
| Rechallenge | ||||||||
| Applied | 338 (33.67%) | 233 (24.84%) | 310 (34.83%) | 187 (31.22%) | 148 (36.36%) | 95 (30.84%) | 16 (22.54%) | 17 (34.00%) |
| Positive | 131 (38.76%) | 75 (32.19%) | 115 (37.10%) | 68 (36.36%) | 50 (33.78%) | 29 (33.78%) | 7 (43.75%) | 4 (23.53%) |
| Negative | 207 (61.24%) | 158 (67.81%) | 195 (62.90%) | 119 (63.64%) | 98 (66.22%) | 66 (66.22%) | 9 (56.25%) | 13 (76.47%) |
| Not applied | 666 (66.33%) | 705 (75.16%) | 580 (65.17%) | 412 (68.78%) | 259 (63.64%) | 213 (69.16%) | 55 (77.46%) | 33 (66.00%) |
| Missing | 19 017 | 18 995 | 16 335 | 14 119 | 8731 | 7358 | 1058 | 1110 |
| Outcomes | ||||||||
| Nonserious outcome | 794 (3.97%) | 1739 (8.72%) | 658 (3.82%) | 1089 (7.4%) | 383 (4.19%) | 637 (8.31%) | 89 (7.88%) | 174 (15%) |
| Serious outcome | 19 227 (96.03%) | 18 194 (91.28%) | 16 567 (96.18%) | 13 629 (92.6%) | 8755 (95.81%) | 7029 (91.69%) | 1040 (92.12%) | 986 (85%) |
| Death | 2951 (14.74%) | 6768 (33.95%) | 3202 (18.59%) | 5075 (34.48%) | 2105 (23.04%) | 2743 (35.78%) | 249 (22.05%) | 466 (40.17%) |
| Hospitalisation | 11 649 (58.18%) | 8471 (42.5%) | 10 378 (60.25%) | 6577 (44.69%) | 5473 (59.89%) | 3236 (42.21%) | 613 (54.3%) | 374 (32.24%) |
| Life-threatening | 2039 (10.18%) | 1001 (5.02%) | 1926 (11.18%) | 771 (5.24%) | 1041 (11.39%) | 395 (5.15%) | 97 (8.59%) | 55 (4.74%) |
| Disability | 632 (3.16%) | 328 (1.65%) | 584 (3.39%) | 293 (1.99%) | 359 (3.93%) | 147 (1.92%) | 40 (3.54%) | 20 (1.72%) |
| Required intervention to prevent permanent impairment/damage | 35 (0.17%) | 10 (0.05%) | 48 (0.28%) | 14 (0.1%) | 31 (0.34%) | 9 (0.12%) | 5 (0.44%) | 2 (0.17%) |
| Other serious | 15 095 (75.4%) | 12 210 (61.26%) | 13 004 (75.49%) | 8952 (60.82%) | 6924 (75.77%) | 4678 (61.02%) | 806 (71.39%) | 695 (59.91%) |
| Dosage (Median, q1–q3) (% data included) | ||||||||
| Cumulative total dosage | (662.58, 222.6–1781.61) (12.34%) | (720, 240–2280 (8.89%) | (600, 200–1600) (15%) | (720, 240–2160 (10.91%) | (600, 200–1500) (15.08%) | (600, 216–1800 (10.66%) | (400, 200–1500) (13.91%) | (830, 240–1710 (8.62%) |
| Cumulative total dosage, per kg | (10, 3.51–25) (9.9%) | (9.99, 3.7–27) (6.56%) | (9.38, 3.7–25) (12.23%) | [4–30] (7.74%) | (9.8, 3.98–23.53) (11.85%) | (9.84, 3.92–24.89) (7.77%) | (7.41, 3.92–26.44) (9.65%) | (11.94, 5–30) (5.6%) |
| Total dosage, per shot | (240, 200–710) (55.48%) | (240 200–740) (59.9%) | (240 200–560) (59.58%) | (240 200–840) (60.32%) | (225 200–480) (58.56%) | (240 200–615) (59.31%) | (200 200–400) (55.71%) | (240, 200–480) (54.31%) |
| Total dosage, per shot, per kg | (3, 2.86–9.16) (45.95%) | (3.08, 3–10) (37.95%) | (3.2, 2.99–9.77) (46.8%) | (3.45, 3–10) (39.4%) | (3.29, 3–9.23) (44.97%) | (3.8, 3–10 (36.15%) | (3.12, 2.84–6) (39.06%) | (3.57, 2.99–10 (27.84%) |
| Treatment regimen | ||||||||
| No additional chemotherapy | 16 126 (80.55%) | 17 131 (85.94%) | 13 833 (80.31%) | 12 542 (85.22%) | 7838 (85.77%) | 6807 (88.79%) | 1052 (93.18%) | 1102 (95%) |
| Additional chemotherapy | 3895 (19.45%) | 2802 (14.06%) | 3392 (19.69%) | 2176 (14.78%) | 1300 (14.23%) | 859 (11.21%) | 77 (6.82%) | 58 (5%) |
| No additional targeted therapy | 16 923 (84.53%) | 17 420 (87.39%) | 14 630 (84.93%) | 12 934 (87.88%) | 8002 (87.57%) | 6821 (88.98%) | 1018 (90.17%) | 1047 (90.26%) |
| Additional targeted therapy | 3098 (15.47%) | 2513 (12.61%) | 2595 (15.07%) | 1784 (12.12%) | 1136 (12.43%) | 845 (11.02%) | 111 (9.83%) | 113 (9.74%) |
| No polytherapy | 15 040 (75.12%) | 16 536 (82.96%) | 13 680 (79.42%) | 12 441 (84.53%) | 7542 (82.53%) | 6659 (86.86%) | 1004 (88.93%) | 1028 (88.62%) |
| Polytherapy | 4981 (24.88%) | 3397 (17.04%) | 3545 (20.58%) | 2277 (15.47%) | 1596 (17.47%) | 1007 (13.14%) | 125 (11.07%) | 132 (11.38%) |
| Number of different immunotherapy agents used | ||||||||
| Monotherapy | 15 040 (75.12%) | 16 536 (82.96%) | 13 680 (79.42%) | 12 441 (84.53%) | 7542 (82.53%) | 6659 (86.86%) | 1004 (88.93%) | 1028 (88.62%) |
| Anti-PD-1 | 10 581 (52.85%) | 11 642 (58.41%) | 9888 (57.4%) | 8444 (57.37%) | 5547 (60.7%) | 4712 (61.47%) | 796 (70.5%) | 808 (69.66%) |
| Nivolumab | 5650 (28.22%) | 7445 (37.35%) | 5116 (29.7%) | 5222 (35.48%) | 2705 (29.6%) | 2637 (34.4%) | 330 (29.23%) | 419 (36.12%) |
| Pembrolizumab | 4859 (24.27%) | 4116 (20.65%) | 4700 (27.29%) | 3151 (21.41%) | 2794 (30.58%) | 2038 (26.58%) | 441 (39.06%) | 360 (31.03%) |
| Cemiplimab | 52 (0.26%) | 49 (0.25%) | 57 (0.33%) | 43 (0.29%) | 45 (0.49%) | 34 (0.44%) | 23 (2.04%) | 29 (2.5%) |
| Dostarlimab | 20 (0.1%) | 32 (0.16%) | 15 (0.09%) | 28 (0.19%) | 3 (0.03%) | 3 (0.04%) | 2 (0.18%) | 0 (0%) |
| Anti-PD-L1 | 3551 (17.74%) | 4322 (21.68%) | 3251 (18.87%) | 3667 (24.92%) | 1709 (18.7%) | 1788 (23.32%) | 174 (15.41%) | 203 (17.5%) |
| Atezolizumab | 2653 (13.25%) | 2999 (15.05%) | 2289 (13.29%) | 2315 (15.73%) | 1161 (12.71%) | 1075 (14.02%) | 124 (10.98%) | 122 (10.52%) |
| Durvalumab | 715 (3.57%) | 1063 (5.33%) | 755 (4.38%) | 1095 (7.44%) | 409 (4.48%) | 524 (6.84%) | 23 (2.04%) | 46 (3.97%) |
| Avelumab | 183 (0.91%) | 260 (1.3%) | 207 (1.2%) | 257 (1.75%) | 139 (1.52%) | 189 (2.47%) | 27 (2.39%) | 35 (3.02%) |
| Anti-CTLA-4 | 908 (4.54%) | 572 (2.87%) | 541 (3.14%) | 330 (2.24%) | 286 (3.13%) | 159 (2.07%) | 34 (3.01%) | 17 (1.47%) |
| Ipilimumab | 906 (4.53%) | 569 (2.85%) | 540 (3.13%) | 329 (2.24%) | 285 (3.12%) | 159 (2.07%) | 34 (3.01%) | 17 (1.47%) |
| Tremelimumab | 2 (0.01%) | 3 (0.02%) | 1 (0.01%) | 1 (0.01%) | 1 (0.01%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dual therapy | 4891 (24.43%) | 3363 (16.87%) | 3472 (20.16%) | 2247 (15.27%) | 1573 (17.21%) | 989 (12.9%) | 123 (10.89%) | 131 (11.29%) |
| Nivolumab + ipilimumab | 4441 (22.18%) | 3023 (15.17%) | 3113 (18.07%) | 1978 (13.44%) | 1411 (15.44%) | 884 (11.53%) | 115 (10.19%) | 118 (10.17%) |
| Nivolumab + pembrolizumab | 36 (0.18%) | 15 (0.08%) | 35 (0.2%) | 16 (0.11%) | 17 (0.19%) | 6 (0.08%) | 1 (0.09%) | 2 (0.17%) |
| Pembrolizumab + ipilimumab | 120 (0.6%) | 53 (0.27%) | 71 (0.41%) | 16 (0.11%) | 31 (0.34%) | 13 (0.17%) | 2 (0.18%) | 2 (0.17%) |
| Nivolumab + relatlimab | 35 (0.17%) | 73 (0.37%) | 39 (0.23%) | 51 (0.35%) | 23 (0.25%) | 28 (0.37%) | 2 (0.18%) | 7 (0.6%) |
| Durvalumab + tremelimumab | 228 (1.14%) | 173 (0.87%) | 192 (1.11%) | 159 (1.08%) | 78 (0.85%) | 44 (0.57%) | 3 (0.27%) | 1 (0.09%) |
| Triple therapy or more | 90 (0.45%) | 30 (0.15%) | 73 (0.42%) | 30 (0.2%) | 23 (0.25%) | 18 (0.23%) | 2 (0.18%) | 1 (0.09%) |
| Nivolumab + pembrolizumab + atezolizumab | 0 (0%) | 14 (0.07%) | 0 (0%) | 21 (0.14%) | 2 (0.02%) | 5 (0.07%) | 0 (0%) | 1 (0.09%) |
| Nivolumab + ipilimumab + relatlimab | 12 (0.06%) | 9 (0.05%) | 16 (0.09%) | 5 (0.03%) | 4 (0.04%) | 12 (0.16%) | 0 (0%) | 0 (0%) |
| Number of different chemotherapy agents used | ||||||||
| None | 16 126 (80.55%) | 17 131 (85.94%) | 13 833 (80.31%) | 12 542 (85.22%) | 7838 (85.77%) | 6807 (88.79%) | 1052 (93.18%) | 1102 (95%) |
| One | 875 (4.37%) | 787 (3.95%) | 682 (3.96%) | 509 (3.46%) | 287 (3.14%) | 226 (2.95%) | 28 (2.48%) | 21 (1.81%) |
| Two or more | 3020 (15.08%) | 2015 (10.11%) | 2710 (15.73%) | 1667 (11.33%) | 1013 (11.09%) | 633 (8.26%) | 49 (4.34%) | 37 (3.19%) |
| Number of different targeted therapy agents used | ||||||||
| None | 16 923 (84.53%) | 17 420 (87.39%) | 14 630 (84.93%) | 12 934 (87.88%) | 8002 (87.57%) | 6821 (88.98%) | 1018 (90.17%) | 1047 (90.26%) |
| One | 2632 (13.15%) | 2228 (11.18%) | 2389 (13.87%) | 1645 (11.18%) | 1053 (11.52%) | 799 (10.42%) | 105 (9.3%) | 109 (9.4%) |
| Two or more | 466 (2.33%) | 285 (1.43%) | 206 (1.2%) | 139 (0.94%) | 83 (0.91%) | 46 (0.6%) | 6 (0.53%) | 4 (0.34%) |
Demographics, clinical characteristics and age-based differences in patients with AEs following ICI administration reported in the FAERS database
| Clinical characteristics . | Patients aged 18–64 (%) . | Patients aged 65–74 (%) . | Patients aged 75–84 (%) . | Patients aged 85+ (%) . | ||||
|---|---|---|---|---|---|---|---|---|
| irAE cases n = 20,021 . | Non- irAE cases n = 19,933 . | irAE cases n = 17,225 . | Non- irAE cases n = 14,718 . | irAE cases n = 9138 . | Non- irAE cases n = 7666 . | irAE cases n = 1129 . | Non- irAE cases n = 1160 . | |
| Sex | ||||||||
| Male | 11 374 (57.37%) | 11 414 (58.56%) | 11 570 (67.95%) | 9769 (67.96%) | 6124 (68.01%) | 5065 (68.00%) | 716 (64.57%) | 713 (64.56%) |
| Female | 8451 (42.63%) | 8076 (41.44%) | 5464 (32.05%) | 4606 (32.04%) | 2882 (31.99%) | 2391 (32.00%) | 393 (35.43%) | 403 (35.44%) |
| Missing | 196 | 443 | 191 | 343 | 132 | 210 | 20 | 44 |
| Age (Median, q1–q3, % data included) | (56, 50–61, 100%) | (56, 49–61 (100%) | (70, 67–72, 100%) | (69, 67–72 (100%) | (78, 76–80, 100%) | (78, 76–80 (100%) | (86, 85–88, 100%) | (87, 85–89) (100%) |
| Time to onset (Median, q1–q3, % data included) | (41, 14–105) (57.99%) | (44, 14–124) (52.74%) | (42, 14–108) (59.64%) | (46, 14–129 (54.48%) | (41, 14–107) (58.35%) | (48, 14–131 (51.41%) | (44.5, 18–123.5) (50.84%) | (43, 11–144.25 (40.34%) |
| Reporter type | ||||||||
| Healthcare worker | 16 896 (84.83%) | 14 455 (73.52%) | 14 297 (83.67%) | 10 781 (74.28%) | 7536 (83.23%) | 5658 (75.11%) | 914 (81.39%) | 786 (68.59%) |
| Consumer | 3019 (15.17%) | 5205 (26.48%) | 2812 (16.77%) | 3733 (25.72%) | 1526 (16.77%) | 1875 (24.89%) | 209 (18.61%) | 360 (31.41%) |
| Missing | 106 | 273 | 116 | 204 | 76 | 133 | 6 | 14 |
| Income level by country | ||||||||
| High income | 17 111 (91.95%) | 15 167 (84.76%) | 15 226 (94.73%) | 11 755 (89.46%) | 8267 (96.59%) | 6446 (92.98%) | 1057 (98.14%) | 1021 (94.28%) |
| Upper middle income | 1382 (7.43%) | 1969 (11.00%) | 776 (4.83%) | 1084 (8.25%) | 266 (3.11%) | 388 (5.60%) | 20 (1.86%) | 51 (4.71%) |
| Lower to middle income | 115 (0.62%) | 758 (4.24%) | 71 (0.44%) | 301 (2.29%) | 26 (0.30%) | 99 (1.43%) | 0 (0%) | 11 (1.02%) |
| Missing | 1413 | 2039 | 1152 | 1578 | 579 | 733 | 52 | 77 |
| Received year | ||||||||
| 2023 | 2738 (13.67%) | 2338 (11.73%) | 2449 (14.22%) | 1758 (11.94%) | 1354 (14.82%) | 991 (12.94%) | 160 (14.17%) | 144 (12.41%) |
| 2022 | 3085 (15.40%) | 3355 (16.83%) | 2876 (16.7%) | 2548 (17.31%) | 1558 (17.05%) | 1340 (17.49%) | 189 (16.74%) | 220 (18.97%) |
| 2021 | 2977 (14.86%) | 2880 (14.45%) | 2676 (15.54%) | 2199 (14.94%) | 1454 (15.91%) | 1160 (15.13%) | 174 (15.41%) | 163 (14.05%) |
| 2020 | 2610 (13.03%) | 2411 (12.1%) | 2258 (13.11%) | 1814 (12.33%) | 1202 (13.15%) | 962 (12.55%) | 159 (14.08%) | 161 (13.88%) |
| 2019 | 2840 (14.18%) | 2683 (13.46%) | 2479 (14.39%) | 2031 (13.8%) | 1299 (14.22%) | 1130 (14.74%) | 150 (13.29%) | 154 (13.28%) |
| 2018 | 2438 (12.17%) | 2406 (12.07%) | 2074 (12.04%) | 1811 (12.3%) | 1049 (11.48%) | 921 (12.02%) | 149 (13.2%) | 133 (11.47%) |
| 2017 | 1632 (8.15%) | 1778 (8.92%) | 1267 (7.36%) | 1242 (8.44%) | 648 (7.09%) | 577 (7.54%) | 73 (6.47%) | 91 (7.84%) |
| 2016 | 1013 (5.06%) | 1260 (6.32%) | 676 (3.92%) | 862 (5.86%) | 371 (4.06%) | 408 (5.32%) | 48 (4.25%) | 74 (6.38%) |
| 2015 | 687 (3.43%) | 820 (4.12%) | 464 (2.69%) | 452 (3.08%) | 202 (2.21%) | 173 (2.27%) | 27 (2.39%) | 20 (1.72%) |
| Missing | 1 | 2 | 6 | 1 | 1 | 4 | 0 | 0 |
| Indication organ/system | ||||||||
| Head and neck | 589 (3.07%) | 997 (5.46%) | 441 (2.67%) | 568 (4.19%) | 211 (2.41%) | 239 (3.39%) | 26 (2.43%) | 43 (3.22%) |
| Lung | 5770 (30.07%) | 5511 (30.20%) | 6722 (40.66%) | 5530 (40.83%) | 3236 (37.03%) | 2596 (36.88%) | 287 (26.85%) | 299 (29.34%) |
| Urogenital | 2702 (14.08%) | 2308 (12.65%) | 2831 (17.12%) | 2101 (15.51%) | 1614 (18.43%) | 1248 (17.73%) | 197 (18.43%) | 169 (16.58%) |
| Gynecologic | 798 (4.16%) | 757 (4.15%) | 478 (2.89%) | 392 (2.89%) | 168 (1.92%) | 173 (2.46%) | 7 (0.65%) | 16 (1.57%) |
| Breast | 965 (5.03%) | 799 (4.38%) | 251 (1.52%) | 170 (1.26%) | 80 (0.92%) | 71 (1.01%) | 7 (0.65%) | 6 (0.59%) |
| Haematopoietic and lymphoid | 455 (2.37%) | 522 (2.86%) | 242 (1.46%) | 261 (1.93%) | 133 (1.52%) | 165 (2.34%) | 18 (1.68%) | 26 (2.55%) |
| Gastrointestinal | 1143 (5.96%) | 1614 (8.84%) | 979 (5.92%) | 1031 (7.61%) | 528 (6.04%) | 514 (7.3%) | 60 (5.61%) | 63 (6.18%) |
| Other indications | 682 (3.55%) | 801 (4.39%) | 441 (2.67%) | 428 (3.16%) | 207 (2.37%) | 209 (2.97%) | 26 (2.43%) | 35 (3.43%) |
| Hepatopancreatobiliary | 759 (3.96%) | 1044 (5.72%) | 735 (4.45%) | 851 (6.28%) | 435 (4.98%) | 444 (6.31%) | 69 (6.45%) | 71 (6.97%) |
| Skin | 4917 (25.63%) | 3057 (16.75%) | 3082 (18.64%) | 1738 (12.83%) | 1904 (21.79%) | 1128 (16.02%) | 352 (32.93%) | 244 (23.95%) |
| Other thoracic (cardiac, mesothelioma, thymus) | 123 (0.64%) | 159 (0.87%) | 223 (1.35%) | 212 (1.57%) | 171 (1.96%) | 160 (2.27%) | 13 (1.22%) | 21 (2.06%) |
| Musculoskeletal | 120 (0.63%) | 259 (1.42%) | 45 (0.27%) | 101 (0.75%) | 32 (0.37%) | 42 (0.60%) | 4 (0.37%) | 16 (1.57%) |
| CNS | 110 (0.57%) | 318 (1.74%) | 32 (0.19%) | 110 (0.81%) | 6 (0.07%) | 31 (0.44%) | 1 (0.09%) | 2 (0.20%) |
| Endocrine | 54 (0.28%) | 103 (0.56%) | 32 (0.19%) | 51 (0.38%) | 13 (0.15%) | 20 (0.28%) | 2 (0.19%) | 8 (0.79%) |
| Unspecified or missing | 834 | 1684 | 691 | 1174 | 400 | 626 | 60 | 141 |
| Dechallenge | ||||||||
| Applied | 7605 (81.13%) | 3661 (43.77%) | 7067 (79.51%) | 3275 (50.24%) | 3715 (77.48%) | 1661 (47.88%) | 436 (73.90%) | 200 (36.63%) |
| Positive | 6457 (84.90%) | 2907 (79.40%) | 6001 (84.92%) | 2550 (77.86%) | 3118 (83.93%) | 1279 (77.00%) | 357 (81.88%) | 146 (73.00%) |
| Negative | 1148 (15.10%) | 754 (20.60%) | 1066 (15.08%) | 725 (22.14%) | 597 (16.07%) | 382 (23.00%) | 79 (18.12%) | 54 (27.00%) |
| Not applied | 1748 (18.87%) | 4705 (56.23%) | 1820 (20.49%) | 3245 (49.76%) | 1079 (22.52%) | 1808 (52.12%) | 154 (26.1%) | 346 (63.37%) |
| Missing | 10 668 | 11 567 | 8338 | 8198 | 4344 | 4197 | 539 | 614 |
| Rechallenge | ||||||||
| Applied | 338 (33.67%) | 233 (24.84%) | 310 (34.83%) | 187 (31.22%) | 148 (36.36%) | 95 (30.84%) | 16 (22.54%) | 17 (34.00%) |
| Positive | 131 (38.76%) | 75 (32.19%) | 115 (37.10%) | 68 (36.36%) | 50 (33.78%) | 29 (33.78%) | 7 (43.75%) | 4 (23.53%) |
| Negative | 207 (61.24%) | 158 (67.81%) | 195 (62.90%) | 119 (63.64%) | 98 (66.22%) | 66 (66.22%) | 9 (56.25%) | 13 (76.47%) |
| Not applied | 666 (66.33%) | 705 (75.16%) | 580 (65.17%) | 412 (68.78%) | 259 (63.64%) | 213 (69.16%) | 55 (77.46%) | 33 (66.00%) |
| Missing | 19 017 | 18 995 | 16 335 | 14 119 | 8731 | 7358 | 1058 | 1110 |
| Outcomes | ||||||||
| Nonserious outcome | 794 (3.97%) | 1739 (8.72%) | 658 (3.82%) | 1089 (7.4%) | 383 (4.19%) | 637 (8.31%) | 89 (7.88%) | 174 (15%) |
| Serious outcome | 19 227 (96.03%) | 18 194 (91.28%) | 16 567 (96.18%) | 13 629 (92.6%) | 8755 (95.81%) | 7029 (91.69%) | 1040 (92.12%) | 986 (85%) |
| Death | 2951 (14.74%) | 6768 (33.95%) | 3202 (18.59%) | 5075 (34.48%) | 2105 (23.04%) | 2743 (35.78%) | 249 (22.05%) | 466 (40.17%) |
| Hospitalisation | 11 649 (58.18%) | 8471 (42.5%) | 10 378 (60.25%) | 6577 (44.69%) | 5473 (59.89%) | 3236 (42.21%) | 613 (54.3%) | 374 (32.24%) |
| Life-threatening | 2039 (10.18%) | 1001 (5.02%) | 1926 (11.18%) | 771 (5.24%) | 1041 (11.39%) | 395 (5.15%) | 97 (8.59%) | 55 (4.74%) |
| Disability | 632 (3.16%) | 328 (1.65%) | 584 (3.39%) | 293 (1.99%) | 359 (3.93%) | 147 (1.92%) | 40 (3.54%) | 20 (1.72%) |
| Required intervention to prevent permanent impairment/damage | 35 (0.17%) | 10 (0.05%) | 48 (0.28%) | 14 (0.1%) | 31 (0.34%) | 9 (0.12%) | 5 (0.44%) | 2 (0.17%) |
| Other serious | 15 095 (75.4%) | 12 210 (61.26%) | 13 004 (75.49%) | 8952 (60.82%) | 6924 (75.77%) | 4678 (61.02%) | 806 (71.39%) | 695 (59.91%) |
| Dosage (Median, q1–q3) (% data included) | ||||||||
| Cumulative total dosage | (662.58, 222.6–1781.61) (12.34%) | (720, 240–2280 (8.89%) | (600, 200–1600) (15%) | (720, 240–2160 (10.91%) | (600, 200–1500) (15.08%) | (600, 216–1800 (10.66%) | (400, 200–1500) (13.91%) | (830, 240–1710 (8.62%) |
| Cumulative total dosage, per kg | (10, 3.51–25) (9.9%) | (9.99, 3.7–27) (6.56%) | (9.38, 3.7–25) (12.23%) | [4–30] (7.74%) | (9.8, 3.98–23.53) (11.85%) | (9.84, 3.92–24.89) (7.77%) | (7.41, 3.92–26.44) (9.65%) | (11.94, 5–30) (5.6%) |
| Total dosage, per shot | (240, 200–710) (55.48%) | (240 200–740) (59.9%) | (240 200–560) (59.58%) | (240 200–840) (60.32%) | (225 200–480) (58.56%) | (240 200–615) (59.31%) | (200 200–400) (55.71%) | (240, 200–480) (54.31%) |
| Total dosage, per shot, per kg | (3, 2.86–9.16) (45.95%) | (3.08, 3–10) (37.95%) | (3.2, 2.99–9.77) (46.8%) | (3.45, 3–10) (39.4%) | (3.29, 3–9.23) (44.97%) | (3.8, 3–10 (36.15%) | (3.12, 2.84–6) (39.06%) | (3.57, 2.99–10 (27.84%) |
| Treatment regimen | ||||||||
| No additional chemotherapy | 16 126 (80.55%) | 17 131 (85.94%) | 13 833 (80.31%) | 12 542 (85.22%) | 7838 (85.77%) | 6807 (88.79%) | 1052 (93.18%) | 1102 (95%) |
| Additional chemotherapy | 3895 (19.45%) | 2802 (14.06%) | 3392 (19.69%) | 2176 (14.78%) | 1300 (14.23%) | 859 (11.21%) | 77 (6.82%) | 58 (5%) |
| No additional targeted therapy | 16 923 (84.53%) | 17 420 (87.39%) | 14 630 (84.93%) | 12 934 (87.88%) | 8002 (87.57%) | 6821 (88.98%) | 1018 (90.17%) | 1047 (90.26%) |
| Additional targeted therapy | 3098 (15.47%) | 2513 (12.61%) | 2595 (15.07%) | 1784 (12.12%) | 1136 (12.43%) | 845 (11.02%) | 111 (9.83%) | 113 (9.74%) |
| No polytherapy | 15 040 (75.12%) | 16 536 (82.96%) | 13 680 (79.42%) | 12 441 (84.53%) | 7542 (82.53%) | 6659 (86.86%) | 1004 (88.93%) | 1028 (88.62%) |
| Polytherapy | 4981 (24.88%) | 3397 (17.04%) | 3545 (20.58%) | 2277 (15.47%) | 1596 (17.47%) | 1007 (13.14%) | 125 (11.07%) | 132 (11.38%) |
| Number of different immunotherapy agents used | ||||||||
| Monotherapy | 15 040 (75.12%) | 16 536 (82.96%) | 13 680 (79.42%) | 12 441 (84.53%) | 7542 (82.53%) | 6659 (86.86%) | 1004 (88.93%) | 1028 (88.62%) |
| Anti-PD-1 | 10 581 (52.85%) | 11 642 (58.41%) | 9888 (57.4%) | 8444 (57.37%) | 5547 (60.7%) | 4712 (61.47%) | 796 (70.5%) | 808 (69.66%) |
| Nivolumab | 5650 (28.22%) | 7445 (37.35%) | 5116 (29.7%) | 5222 (35.48%) | 2705 (29.6%) | 2637 (34.4%) | 330 (29.23%) | 419 (36.12%) |
| Pembrolizumab | 4859 (24.27%) | 4116 (20.65%) | 4700 (27.29%) | 3151 (21.41%) | 2794 (30.58%) | 2038 (26.58%) | 441 (39.06%) | 360 (31.03%) |
| Cemiplimab | 52 (0.26%) | 49 (0.25%) | 57 (0.33%) | 43 (0.29%) | 45 (0.49%) | 34 (0.44%) | 23 (2.04%) | 29 (2.5%) |
| Dostarlimab | 20 (0.1%) | 32 (0.16%) | 15 (0.09%) | 28 (0.19%) | 3 (0.03%) | 3 (0.04%) | 2 (0.18%) | 0 (0%) |
| Anti-PD-L1 | 3551 (17.74%) | 4322 (21.68%) | 3251 (18.87%) | 3667 (24.92%) | 1709 (18.7%) | 1788 (23.32%) | 174 (15.41%) | 203 (17.5%) |
| Atezolizumab | 2653 (13.25%) | 2999 (15.05%) | 2289 (13.29%) | 2315 (15.73%) | 1161 (12.71%) | 1075 (14.02%) | 124 (10.98%) | 122 (10.52%) |
| Durvalumab | 715 (3.57%) | 1063 (5.33%) | 755 (4.38%) | 1095 (7.44%) | 409 (4.48%) | 524 (6.84%) | 23 (2.04%) | 46 (3.97%) |
| Avelumab | 183 (0.91%) | 260 (1.3%) | 207 (1.2%) | 257 (1.75%) | 139 (1.52%) | 189 (2.47%) | 27 (2.39%) | 35 (3.02%) |
| Anti-CTLA-4 | 908 (4.54%) | 572 (2.87%) | 541 (3.14%) | 330 (2.24%) | 286 (3.13%) | 159 (2.07%) | 34 (3.01%) | 17 (1.47%) |
| Ipilimumab | 906 (4.53%) | 569 (2.85%) | 540 (3.13%) | 329 (2.24%) | 285 (3.12%) | 159 (2.07%) | 34 (3.01%) | 17 (1.47%) |
| Tremelimumab | 2 (0.01%) | 3 (0.02%) | 1 (0.01%) | 1 (0.01%) | 1 (0.01%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dual therapy | 4891 (24.43%) | 3363 (16.87%) | 3472 (20.16%) | 2247 (15.27%) | 1573 (17.21%) | 989 (12.9%) | 123 (10.89%) | 131 (11.29%) |
| Nivolumab + ipilimumab | 4441 (22.18%) | 3023 (15.17%) | 3113 (18.07%) | 1978 (13.44%) | 1411 (15.44%) | 884 (11.53%) | 115 (10.19%) | 118 (10.17%) |
| Nivolumab + pembrolizumab | 36 (0.18%) | 15 (0.08%) | 35 (0.2%) | 16 (0.11%) | 17 (0.19%) | 6 (0.08%) | 1 (0.09%) | 2 (0.17%) |
| Pembrolizumab + ipilimumab | 120 (0.6%) | 53 (0.27%) | 71 (0.41%) | 16 (0.11%) | 31 (0.34%) | 13 (0.17%) | 2 (0.18%) | 2 (0.17%) |
| Nivolumab + relatlimab | 35 (0.17%) | 73 (0.37%) | 39 (0.23%) | 51 (0.35%) | 23 (0.25%) | 28 (0.37%) | 2 (0.18%) | 7 (0.6%) |
| Durvalumab + tremelimumab | 228 (1.14%) | 173 (0.87%) | 192 (1.11%) | 159 (1.08%) | 78 (0.85%) | 44 (0.57%) | 3 (0.27%) | 1 (0.09%) |
| Triple therapy or more | 90 (0.45%) | 30 (0.15%) | 73 (0.42%) | 30 (0.2%) | 23 (0.25%) | 18 (0.23%) | 2 (0.18%) | 1 (0.09%) |
| Nivolumab + pembrolizumab + atezolizumab | 0 (0%) | 14 (0.07%) | 0 (0%) | 21 (0.14%) | 2 (0.02%) | 5 (0.07%) | 0 (0%) | 1 (0.09%) |
| Nivolumab + ipilimumab + relatlimab | 12 (0.06%) | 9 (0.05%) | 16 (0.09%) | 5 (0.03%) | 4 (0.04%) | 12 (0.16%) | 0 (0%) | 0 (0%) |
| Number of different chemotherapy agents used | ||||||||
| None | 16 126 (80.55%) | 17 131 (85.94%) | 13 833 (80.31%) | 12 542 (85.22%) | 7838 (85.77%) | 6807 (88.79%) | 1052 (93.18%) | 1102 (95%) |
| One | 875 (4.37%) | 787 (3.95%) | 682 (3.96%) | 509 (3.46%) | 287 (3.14%) | 226 (2.95%) | 28 (2.48%) | 21 (1.81%) |
| Two or more | 3020 (15.08%) | 2015 (10.11%) | 2710 (15.73%) | 1667 (11.33%) | 1013 (11.09%) | 633 (8.26%) | 49 (4.34%) | 37 (3.19%) |
| Number of different targeted therapy agents used | ||||||||
| None | 16 923 (84.53%) | 17 420 (87.39%) | 14 630 (84.93%) | 12 934 (87.88%) | 8002 (87.57%) | 6821 (88.98%) | 1018 (90.17%) | 1047 (90.26%) |
| One | 2632 (13.15%) | 2228 (11.18%) | 2389 (13.87%) | 1645 (11.18%) | 1053 (11.52%) | 799 (10.42%) | 105 (9.3%) | 109 (9.4%) |
| Two or more | 466 (2.33%) | 285 (1.43%) | 206 (1.2%) | 139 (0.94%) | 83 (0.91%) | 46 (0.6%) | 6 (0.53%) | 4 (0.34%) |
| Clinical characteristics . | Patients aged 18–64 (%) . | Patients aged 65–74 (%) . | Patients aged 75–84 (%) . | Patients aged 85+ (%) . | ||||
|---|---|---|---|---|---|---|---|---|
| irAE cases n = 20,021 . | Non- irAE cases n = 19,933 . | irAE cases n = 17,225 . | Non- irAE cases n = 14,718 . | irAE cases n = 9138 . | Non- irAE cases n = 7666 . | irAE cases n = 1129 . | Non- irAE cases n = 1160 . | |
| Sex | ||||||||
| Male | 11 374 (57.37%) | 11 414 (58.56%) | 11 570 (67.95%) | 9769 (67.96%) | 6124 (68.01%) | 5065 (68.00%) | 716 (64.57%) | 713 (64.56%) |
| Female | 8451 (42.63%) | 8076 (41.44%) | 5464 (32.05%) | 4606 (32.04%) | 2882 (31.99%) | 2391 (32.00%) | 393 (35.43%) | 403 (35.44%) |
| Missing | 196 | 443 | 191 | 343 | 132 | 210 | 20 | 44 |
| Age (Median, q1–q3, % data included) | (56, 50–61, 100%) | (56, 49–61 (100%) | (70, 67–72, 100%) | (69, 67–72 (100%) | (78, 76–80, 100%) | (78, 76–80 (100%) | (86, 85–88, 100%) | (87, 85–89) (100%) |
| Time to onset (Median, q1–q3, % data included) | (41, 14–105) (57.99%) | (44, 14–124) (52.74%) | (42, 14–108) (59.64%) | (46, 14–129 (54.48%) | (41, 14–107) (58.35%) | (48, 14–131 (51.41%) | (44.5, 18–123.5) (50.84%) | (43, 11–144.25 (40.34%) |
| Reporter type | ||||||||
| Healthcare worker | 16 896 (84.83%) | 14 455 (73.52%) | 14 297 (83.67%) | 10 781 (74.28%) | 7536 (83.23%) | 5658 (75.11%) | 914 (81.39%) | 786 (68.59%) |
| Consumer | 3019 (15.17%) | 5205 (26.48%) | 2812 (16.77%) | 3733 (25.72%) | 1526 (16.77%) | 1875 (24.89%) | 209 (18.61%) | 360 (31.41%) |
| Missing | 106 | 273 | 116 | 204 | 76 | 133 | 6 | 14 |
| Income level by country | ||||||||
| High income | 17 111 (91.95%) | 15 167 (84.76%) | 15 226 (94.73%) | 11 755 (89.46%) | 8267 (96.59%) | 6446 (92.98%) | 1057 (98.14%) | 1021 (94.28%) |
| Upper middle income | 1382 (7.43%) | 1969 (11.00%) | 776 (4.83%) | 1084 (8.25%) | 266 (3.11%) | 388 (5.60%) | 20 (1.86%) | 51 (4.71%) |
| Lower to middle income | 115 (0.62%) | 758 (4.24%) | 71 (0.44%) | 301 (2.29%) | 26 (0.30%) | 99 (1.43%) | 0 (0%) | 11 (1.02%) |
| Missing | 1413 | 2039 | 1152 | 1578 | 579 | 733 | 52 | 77 |
| Received year | ||||||||
| 2023 | 2738 (13.67%) | 2338 (11.73%) | 2449 (14.22%) | 1758 (11.94%) | 1354 (14.82%) | 991 (12.94%) | 160 (14.17%) | 144 (12.41%) |
| 2022 | 3085 (15.40%) | 3355 (16.83%) | 2876 (16.7%) | 2548 (17.31%) | 1558 (17.05%) | 1340 (17.49%) | 189 (16.74%) | 220 (18.97%) |
| 2021 | 2977 (14.86%) | 2880 (14.45%) | 2676 (15.54%) | 2199 (14.94%) | 1454 (15.91%) | 1160 (15.13%) | 174 (15.41%) | 163 (14.05%) |
| 2020 | 2610 (13.03%) | 2411 (12.1%) | 2258 (13.11%) | 1814 (12.33%) | 1202 (13.15%) | 962 (12.55%) | 159 (14.08%) | 161 (13.88%) |
| 2019 | 2840 (14.18%) | 2683 (13.46%) | 2479 (14.39%) | 2031 (13.8%) | 1299 (14.22%) | 1130 (14.74%) | 150 (13.29%) | 154 (13.28%) |
| 2018 | 2438 (12.17%) | 2406 (12.07%) | 2074 (12.04%) | 1811 (12.3%) | 1049 (11.48%) | 921 (12.02%) | 149 (13.2%) | 133 (11.47%) |
| 2017 | 1632 (8.15%) | 1778 (8.92%) | 1267 (7.36%) | 1242 (8.44%) | 648 (7.09%) | 577 (7.54%) | 73 (6.47%) | 91 (7.84%) |
| 2016 | 1013 (5.06%) | 1260 (6.32%) | 676 (3.92%) | 862 (5.86%) | 371 (4.06%) | 408 (5.32%) | 48 (4.25%) | 74 (6.38%) |
| 2015 | 687 (3.43%) | 820 (4.12%) | 464 (2.69%) | 452 (3.08%) | 202 (2.21%) | 173 (2.27%) | 27 (2.39%) | 20 (1.72%) |
| Missing | 1 | 2 | 6 | 1 | 1 | 4 | 0 | 0 |
| Indication organ/system | ||||||||
| Head and neck | 589 (3.07%) | 997 (5.46%) | 441 (2.67%) | 568 (4.19%) | 211 (2.41%) | 239 (3.39%) | 26 (2.43%) | 43 (3.22%) |
| Lung | 5770 (30.07%) | 5511 (30.20%) | 6722 (40.66%) | 5530 (40.83%) | 3236 (37.03%) | 2596 (36.88%) | 287 (26.85%) | 299 (29.34%) |
| Urogenital | 2702 (14.08%) | 2308 (12.65%) | 2831 (17.12%) | 2101 (15.51%) | 1614 (18.43%) | 1248 (17.73%) | 197 (18.43%) | 169 (16.58%) |
| Gynecologic | 798 (4.16%) | 757 (4.15%) | 478 (2.89%) | 392 (2.89%) | 168 (1.92%) | 173 (2.46%) | 7 (0.65%) | 16 (1.57%) |
| Breast | 965 (5.03%) | 799 (4.38%) | 251 (1.52%) | 170 (1.26%) | 80 (0.92%) | 71 (1.01%) | 7 (0.65%) | 6 (0.59%) |
| Haematopoietic and lymphoid | 455 (2.37%) | 522 (2.86%) | 242 (1.46%) | 261 (1.93%) | 133 (1.52%) | 165 (2.34%) | 18 (1.68%) | 26 (2.55%) |
| Gastrointestinal | 1143 (5.96%) | 1614 (8.84%) | 979 (5.92%) | 1031 (7.61%) | 528 (6.04%) | 514 (7.3%) | 60 (5.61%) | 63 (6.18%) |
| Other indications | 682 (3.55%) | 801 (4.39%) | 441 (2.67%) | 428 (3.16%) | 207 (2.37%) | 209 (2.97%) | 26 (2.43%) | 35 (3.43%) |
| Hepatopancreatobiliary | 759 (3.96%) | 1044 (5.72%) | 735 (4.45%) | 851 (6.28%) | 435 (4.98%) | 444 (6.31%) | 69 (6.45%) | 71 (6.97%) |
| Skin | 4917 (25.63%) | 3057 (16.75%) | 3082 (18.64%) | 1738 (12.83%) | 1904 (21.79%) | 1128 (16.02%) | 352 (32.93%) | 244 (23.95%) |
| Other thoracic (cardiac, mesothelioma, thymus) | 123 (0.64%) | 159 (0.87%) | 223 (1.35%) | 212 (1.57%) | 171 (1.96%) | 160 (2.27%) | 13 (1.22%) | 21 (2.06%) |
| Musculoskeletal | 120 (0.63%) | 259 (1.42%) | 45 (0.27%) | 101 (0.75%) | 32 (0.37%) | 42 (0.60%) | 4 (0.37%) | 16 (1.57%) |
| CNS | 110 (0.57%) | 318 (1.74%) | 32 (0.19%) | 110 (0.81%) | 6 (0.07%) | 31 (0.44%) | 1 (0.09%) | 2 (0.20%) |
| Endocrine | 54 (0.28%) | 103 (0.56%) | 32 (0.19%) | 51 (0.38%) | 13 (0.15%) | 20 (0.28%) | 2 (0.19%) | 8 (0.79%) |
| Unspecified or missing | 834 | 1684 | 691 | 1174 | 400 | 626 | 60 | 141 |
| Dechallenge | ||||||||
| Applied | 7605 (81.13%) | 3661 (43.77%) | 7067 (79.51%) | 3275 (50.24%) | 3715 (77.48%) | 1661 (47.88%) | 436 (73.90%) | 200 (36.63%) |
| Positive | 6457 (84.90%) | 2907 (79.40%) | 6001 (84.92%) | 2550 (77.86%) | 3118 (83.93%) | 1279 (77.00%) | 357 (81.88%) | 146 (73.00%) |
| Negative | 1148 (15.10%) | 754 (20.60%) | 1066 (15.08%) | 725 (22.14%) | 597 (16.07%) | 382 (23.00%) | 79 (18.12%) | 54 (27.00%) |
| Not applied | 1748 (18.87%) | 4705 (56.23%) | 1820 (20.49%) | 3245 (49.76%) | 1079 (22.52%) | 1808 (52.12%) | 154 (26.1%) | 346 (63.37%) |
| Missing | 10 668 | 11 567 | 8338 | 8198 | 4344 | 4197 | 539 | 614 |
| Rechallenge | ||||||||
| Applied | 338 (33.67%) | 233 (24.84%) | 310 (34.83%) | 187 (31.22%) | 148 (36.36%) | 95 (30.84%) | 16 (22.54%) | 17 (34.00%) |
| Positive | 131 (38.76%) | 75 (32.19%) | 115 (37.10%) | 68 (36.36%) | 50 (33.78%) | 29 (33.78%) | 7 (43.75%) | 4 (23.53%) |
| Negative | 207 (61.24%) | 158 (67.81%) | 195 (62.90%) | 119 (63.64%) | 98 (66.22%) | 66 (66.22%) | 9 (56.25%) | 13 (76.47%) |
| Not applied | 666 (66.33%) | 705 (75.16%) | 580 (65.17%) | 412 (68.78%) | 259 (63.64%) | 213 (69.16%) | 55 (77.46%) | 33 (66.00%) |
| Missing | 19 017 | 18 995 | 16 335 | 14 119 | 8731 | 7358 | 1058 | 1110 |
| Outcomes | ||||||||
| Nonserious outcome | 794 (3.97%) | 1739 (8.72%) | 658 (3.82%) | 1089 (7.4%) | 383 (4.19%) | 637 (8.31%) | 89 (7.88%) | 174 (15%) |
| Serious outcome | 19 227 (96.03%) | 18 194 (91.28%) | 16 567 (96.18%) | 13 629 (92.6%) | 8755 (95.81%) | 7029 (91.69%) | 1040 (92.12%) | 986 (85%) |
| Death | 2951 (14.74%) | 6768 (33.95%) | 3202 (18.59%) | 5075 (34.48%) | 2105 (23.04%) | 2743 (35.78%) | 249 (22.05%) | 466 (40.17%) |
| Hospitalisation | 11 649 (58.18%) | 8471 (42.5%) | 10 378 (60.25%) | 6577 (44.69%) | 5473 (59.89%) | 3236 (42.21%) | 613 (54.3%) | 374 (32.24%) |
| Life-threatening | 2039 (10.18%) | 1001 (5.02%) | 1926 (11.18%) | 771 (5.24%) | 1041 (11.39%) | 395 (5.15%) | 97 (8.59%) | 55 (4.74%) |
| Disability | 632 (3.16%) | 328 (1.65%) | 584 (3.39%) | 293 (1.99%) | 359 (3.93%) | 147 (1.92%) | 40 (3.54%) | 20 (1.72%) |
| Required intervention to prevent permanent impairment/damage | 35 (0.17%) | 10 (0.05%) | 48 (0.28%) | 14 (0.1%) | 31 (0.34%) | 9 (0.12%) | 5 (0.44%) | 2 (0.17%) |
| Other serious | 15 095 (75.4%) | 12 210 (61.26%) | 13 004 (75.49%) | 8952 (60.82%) | 6924 (75.77%) | 4678 (61.02%) | 806 (71.39%) | 695 (59.91%) |
| Dosage (Median, q1–q3) (% data included) | ||||||||
| Cumulative total dosage | (662.58, 222.6–1781.61) (12.34%) | (720, 240–2280 (8.89%) | (600, 200–1600) (15%) | (720, 240–2160 (10.91%) | (600, 200–1500) (15.08%) | (600, 216–1800 (10.66%) | (400, 200–1500) (13.91%) | (830, 240–1710 (8.62%) |
| Cumulative total dosage, per kg | (10, 3.51–25) (9.9%) | (9.99, 3.7–27) (6.56%) | (9.38, 3.7–25) (12.23%) | [4–30] (7.74%) | (9.8, 3.98–23.53) (11.85%) | (9.84, 3.92–24.89) (7.77%) | (7.41, 3.92–26.44) (9.65%) | (11.94, 5–30) (5.6%) |
| Total dosage, per shot | (240, 200–710) (55.48%) | (240 200–740) (59.9%) | (240 200–560) (59.58%) | (240 200–840) (60.32%) | (225 200–480) (58.56%) | (240 200–615) (59.31%) | (200 200–400) (55.71%) | (240, 200–480) (54.31%) |
| Total dosage, per shot, per kg | (3, 2.86–9.16) (45.95%) | (3.08, 3–10) (37.95%) | (3.2, 2.99–9.77) (46.8%) | (3.45, 3–10) (39.4%) | (3.29, 3–9.23) (44.97%) | (3.8, 3–10 (36.15%) | (3.12, 2.84–6) (39.06%) | (3.57, 2.99–10 (27.84%) |
| Treatment regimen | ||||||||
| No additional chemotherapy | 16 126 (80.55%) | 17 131 (85.94%) | 13 833 (80.31%) | 12 542 (85.22%) | 7838 (85.77%) | 6807 (88.79%) | 1052 (93.18%) | 1102 (95%) |
| Additional chemotherapy | 3895 (19.45%) | 2802 (14.06%) | 3392 (19.69%) | 2176 (14.78%) | 1300 (14.23%) | 859 (11.21%) | 77 (6.82%) | 58 (5%) |
| No additional targeted therapy | 16 923 (84.53%) | 17 420 (87.39%) | 14 630 (84.93%) | 12 934 (87.88%) | 8002 (87.57%) | 6821 (88.98%) | 1018 (90.17%) | 1047 (90.26%) |
| Additional targeted therapy | 3098 (15.47%) | 2513 (12.61%) | 2595 (15.07%) | 1784 (12.12%) | 1136 (12.43%) | 845 (11.02%) | 111 (9.83%) | 113 (9.74%) |
| No polytherapy | 15 040 (75.12%) | 16 536 (82.96%) | 13 680 (79.42%) | 12 441 (84.53%) | 7542 (82.53%) | 6659 (86.86%) | 1004 (88.93%) | 1028 (88.62%) |
| Polytherapy | 4981 (24.88%) | 3397 (17.04%) | 3545 (20.58%) | 2277 (15.47%) | 1596 (17.47%) | 1007 (13.14%) | 125 (11.07%) | 132 (11.38%) |
| Number of different immunotherapy agents used | ||||||||
| Monotherapy | 15 040 (75.12%) | 16 536 (82.96%) | 13 680 (79.42%) | 12 441 (84.53%) | 7542 (82.53%) | 6659 (86.86%) | 1004 (88.93%) | 1028 (88.62%) |
| Anti-PD-1 | 10 581 (52.85%) | 11 642 (58.41%) | 9888 (57.4%) | 8444 (57.37%) | 5547 (60.7%) | 4712 (61.47%) | 796 (70.5%) | 808 (69.66%) |
| Nivolumab | 5650 (28.22%) | 7445 (37.35%) | 5116 (29.7%) | 5222 (35.48%) | 2705 (29.6%) | 2637 (34.4%) | 330 (29.23%) | 419 (36.12%) |
| Pembrolizumab | 4859 (24.27%) | 4116 (20.65%) | 4700 (27.29%) | 3151 (21.41%) | 2794 (30.58%) | 2038 (26.58%) | 441 (39.06%) | 360 (31.03%) |
| Cemiplimab | 52 (0.26%) | 49 (0.25%) | 57 (0.33%) | 43 (0.29%) | 45 (0.49%) | 34 (0.44%) | 23 (2.04%) | 29 (2.5%) |
| Dostarlimab | 20 (0.1%) | 32 (0.16%) | 15 (0.09%) | 28 (0.19%) | 3 (0.03%) | 3 (0.04%) | 2 (0.18%) | 0 (0%) |
| Anti-PD-L1 | 3551 (17.74%) | 4322 (21.68%) | 3251 (18.87%) | 3667 (24.92%) | 1709 (18.7%) | 1788 (23.32%) | 174 (15.41%) | 203 (17.5%) |
| Atezolizumab | 2653 (13.25%) | 2999 (15.05%) | 2289 (13.29%) | 2315 (15.73%) | 1161 (12.71%) | 1075 (14.02%) | 124 (10.98%) | 122 (10.52%) |
| Durvalumab | 715 (3.57%) | 1063 (5.33%) | 755 (4.38%) | 1095 (7.44%) | 409 (4.48%) | 524 (6.84%) | 23 (2.04%) | 46 (3.97%) |
| Avelumab | 183 (0.91%) | 260 (1.3%) | 207 (1.2%) | 257 (1.75%) | 139 (1.52%) | 189 (2.47%) | 27 (2.39%) | 35 (3.02%) |
| Anti-CTLA-4 | 908 (4.54%) | 572 (2.87%) | 541 (3.14%) | 330 (2.24%) | 286 (3.13%) | 159 (2.07%) | 34 (3.01%) | 17 (1.47%) |
| Ipilimumab | 906 (4.53%) | 569 (2.85%) | 540 (3.13%) | 329 (2.24%) | 285 (3.12%) | 159 (2.07%) | 34 (3.01%) | 17 (1.47%) |
| Tremelimumab | 2 (0.01%) | 3 (0.02%) | 1 (0.01%) | 1 (0.01%) | 1 (0.01%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dual therapy | 4891 (24.43%) | 3363 (16.87%) | 3472 (20.16%) | 2247 (15.27%) | 1573 (17.21%) | 989 (12.9%) | 123 (10.89%) | 131 (11.29%) |
| Nivolumab + ipilimumab | 4441 (22.18%) | 3023 (15.17%) | 3113 (18.07%) | 1978 (13.44%) | 1411 (15.44%) | 884 (11.53%) | 115 (10.19%) | 118 (10.17%) |
| Nivolumab + pembrolizumab | 36 (0.18%) | 15 (0.08%) | 35 (0.2%) | 16 (0.11%) | 17 (0.19%) | 6 (0.08%) | 1 (0.09%) | 2 (0.17%) |
| Pembrolizumab + ipilimumab | 120 (0.6%) | 53 (0.27%) | 71 (0.41%) | 16 (0.11%) | 31 (0.34%) | 13 (0.17%) | 2 (0.18%) | 2 (0.17%) |
| Nivolumab + relatlimab | 35 (0.17%) | 73 (0.37%) | 39 (0.23%) | 51 (0.35%) | 23 (0.25%) | 28 (0.37%) | 2 (0.18%) | 7 (0.6%) |
| Durvalumab + tremelimumab | 228 (1.14%) | 173 (0.87%) | 192 (1.11%) | 159 (1.08%) | 78 (0.85%) | 44 (0.57%) | 3 (0.27%) | 1 (0.09%) |
| Triple therapy or more | 90 (0.45%) | 30 (0.15%) | 73 (0.42%) | 30 (0.2%) | 23 (0.25%) | 18 (0.23%) | 2 (0.18%) | 1 (0.09%) |
| Nivolumab + pembrolizumab + atezolizumab | 0 (0%) | 14 (0.07%) | 0 (0%) | 21 (0.14%) | 2 (0.02%) | 5 (0.07%) | 0 (0%) | 1 (0.09%) |
| Nivolumab + ipilimumab + relatlimab | 12 (0.06%) | 9 (0.05%) | 16 (0.09%) | 5 (0.03%) | 4 (0.04%) | 12 (0.16%) | 0 (0%) | 0 (0%) |
| Number of different chemotherapy agents used | ||||||||
| None | 16 126 (80.55%) | 17 131 (85.94%) | 13 833 (80.31%) | 12 542 (85.22%) | 7838 (85.77%) | 6807 (88.79%) | 1052 (93.18%) | 1102 (95%) |
| One | 875 (4.37%) | 787 (3.95%) | 682 (3.96%) | 509 (3.46%) | 287 (3.14%) | 226 (2.95%) | 28 (2.48%) | 21 (1.81%) |
| Two or more | 3020 (15.08%) | 2015 (10.11%) | 2710 (15.73%) | 1667 (11.33%) | 1013 (11.09%) | 633 (8.26%) | 49 (4.34%) | 37 (3.19%) |
| Number of different targeted therapy agents used | ||||||||
| None | 16 923 (84.53%) | 17 420 (87.39%) | 14 630 (84.93%) | 12 934 (87.88%) | 8002 (87.57%) | 6821 (88.98%) | 1018 (90.17%) | 1047 (90.26%) |
| One | 2632 (13.15%) | 2228 (11.18%) | 2389 (13.87%) | 1645 (11.18%) | 1053 (11.52%) | 799 (10.42%) | 105 (9.3%) | 109 (9.4%) |
| Two or more | 466 (2.33%) | 285 (1.43%) | 206 (1.2%) | 139 (0.94%) | 83 (0.91%) | 46 (0.6%) | 6 (0.53%) | 4 (0.34%) |
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