Table 1.
Baseline characteristics of immune checkpoint inhibitor-related safety reports by age subgroups.
| Characteristics | <18 Years (N = 173) |
18–64 Years (N = 25,252) |
65–74 Years (N = 19,214) |
75–84 Years (N = 9808) |
≥85 Years (N = 1344) |
|---|---|---|---|---|---|
| Median age (IQR), years | 12 (5–15) | 56 (49–61) | 69 (67–72) | 78 (76–80) | 87 (85–88) |
| Patient sex | |||||
| Male | 94 (54.3) | 14,530 (57.5) | 12,850 (66.9) | 6627 (67.6) | 828 (61.6) |
| Female | 74 (42.8) | 10,236 (40.5) | 6038 (31.4) | 3009 (30.7) | 486 (36.2) |
| Not reported | 5 (2.9) | 486 (1.9) | 326 (1.7) | 172 (1.8) | 30 (2.2) |
| Reporting country | |||||
| North America | 84 (48.6) | 9830 (38.9) | 6005 (31.3) | 2991 (30.5) | 586 (43.6) |
| South America | 16 (9.2) | 379 (1.5) | 215 (1.1) | 97 (1.0) | 17 (1.3) |
| Europe | 50 (28.9) | 9042 (35.8) | 6416 (33.4) | 3238 (33.0) | 413 (30.7) |
| Asia | 18 (10.4) | 5107 (20.2) | 5963 (31.0) | 3186 (32.5) | 278 (20.7) |
| Oceania | 3 (1.7) | 734 (2.9) | 564 (2.9) | 282 (2.9) | 49 (3.6) |
| Africa | 2 (1.2) | 160 (0.6) | 51 (0.3) | 14 (0.1) | 1 (0.1) |
| Reporting year | |||||
| 2008 | - | 8 (0) | - | - | - |
| 2009 | - | 26 (0.1) | 1 (0) | 3 (0) | - |
| 2010 | - | 32 (0.1) | 5 (0) | 3 (0) | - |
| 2011 | - | 114 (0.5) | 46 (0.2) | 18 (0.2) | 1 (0.1) |
| 2012 | 5 (2.9) | 397 (1.6) | 185 (1.0) | 92 (0.9) | 14 (1.0) |
| 2013 | 1 (0.6) | 311 (1.2) | 163 (0.8) | 59 (0.6) | 8 (0.6) |
| 2014 | 8 (4.6) | 696 (2.8) | 299 (1.6) | 177 (1.8) | 29 (2.2) |
| 2015 | 9 (5.2) | 1597 (6.3) | 910 (4.7) | 397 (4.0) | 60 (4.5) |
| 2016 | 14 (8.1) | 2415 (9.6) | 1623 (8.4) | 766 (7.8) | 100 (7.4) |
| 2017 | 32 (18.5) | 4090 (16.2) | 3245 (16.9) | 1627 (16.6) | 220 (16.4) |
| 2018 | 42 (24.3) | 5790 (22.9) | 4792 (24.9) | 2435 (24.8) | 334 (24.9) |
| 2019 | 34 (19.7) | 6613 (26.2) | 5739 (29.9) | 3092 (31.5) | 402 (29.9) |
| 2020 (up to 30 August) | 28 (16.2) | 3163 (12.5) | 2206 (11.5) | 1139 (11.6) | 176 (13.1) |
| Reporter qualification | |||||
| Physician | 71 (41.0) | 13,175 (52.2) | 11,624 (60.5) | 6066 (61.8) | 732 (54.5) |
| Other Health Professional | 59 (34.1) | 6227 (24.7) | 3705 (19.3) | 1766 (18.0) | 231 (17.2) |
| Consumer/Non Health Professional | 27 (15.6) | 3457 (13.7) | 1985 (10.3) | 958 (9.8) | 225 (16.7) |
| Pharmacist | 11 (6.4) | 1668 (6.6) | 1380 (7.2) | 755 (7.7) | 112 (8.3) |
| Lawyer | - | 10 (0) | 6 (0) | 2 (0) | - |
| Not reported | 5 (2.9) | 715 (2.8) | 514 (2.7) | 261 (2.7) | 44 (3.3) |
| Seriousness | |||||
| Yes | 135 (78.0) | 20,291 (80.4) | 15,630 (81.3) | 7985 (81.4) | 1046 (77.8) |
| Caused/prolonged hospitalization | 42 (24.3) | 8541 (33.8) | 6958 (36.2) | 3491 (35.6) | 406 (30.2) |
| Death | 29 (16.8) | 4214 (16.7) | 3226 (16.8) | 1838 (18.7) | 290 (21.6) |
| Disabling/incapacitating | 2 (1.2) | 185 (0.7) | 178 (0.9) | 84 (0.9) | 12 (0.9) |
| Life threatening | 11 (6.4) | 1054 (4.2) | 873 (4.5) | 438 (4.5) | 47 (3.5) |
| Congenital anomaly/birth defect | - | 8 (0) | - | 1 (0) | - |
| Other medically important condition | 51 (29.5) | 6264 (24.8) | 4386 (22.8) | 2132 (21.7) | 290 (21.6) |
| Unknown | - | 25 (0.1) | 9 (0) | 1 (0) | 1 (0.1) |
| No | 34 (19.7) | 4445 (17.6) | 3203 (16.7) | 1642 (16.7) | 265 (19.7) |
| Not reported | 4 (2.3) | 516 (2.0) | 381 (2.0) | 181 (1.8) | 33 (2.5) |
| Suspected ICI(s) | |||||
| Anti-CTLA-4 monotherapy | |||||
| ipilimumab | 20 (11.6) | 3382 (13.4) | 1698 (8.8) | 839 (8.6) | 119 (8.9) |
| Anti-PD-1 monotherapy | |||||
| nivolumab | 71 (41.0) | 8960 (35.5) | 7247 (37.7) | 3548 (36.2) | 442 (32.9) |
| pembrolizumab | 49 (28.3) | 6591 (26.1) | 5748 (29.9) | 3379 (34.5) | 540 (40.2) |
| cemiplimab | - | 33 (0.1) | 47 (0.2) | 75 (0.8) | 48 (3.6) |
| Anti-PD-L1 monotherapy | |||||
| atezolizumab | 8 (4.6) | 1993 (7.9) | 1674 (8.7) | 777 (7.9) | 88 (6.5) |
| avelumab | 1 (0.6) | 215 (0.9) | 214 (1.1) | 142 (1.4) | 22 (1.6) |
| durvalumab | 2 (1.2) | 912 (3.6) | 894 (4.7) | 380 (3.9) | 18 (1.3) |
| Combination of anti-PD-1 and anti-CTLA-4 | 13 (7.5) | 1826 (7.2) | 1039 (5.4) | 397 (4.0) | 35 (2.6) |
| ≥2 suspected ICIs but regimen not definable # | 9 (5.2) | 1340 (5.3) | 653 (3.4) | 271 (2.8) | 32 (2.4) |
| Cancer type | |||||
| Lung cancer | 11 (6.4) | 7740 (30.7) | 8127 (42.3) | 3933 (40.1) | 375 (27.9) |
| Malignant melanoma | 31 (17.9) | 6526 (25.8) | 3502 (18.2) | 2137 (21.8) | 418 (31.1) |
| Renal cell carcinoma | 11 (6.4) | 1585 (6.3) | 1299 (6.8) | 570 (5.8) | 62 (4.6) |
| Urothelial carcinoma | 2 (1.2) | 708 (2.8) | 961 (5.0) | 685 (7.0) | 85 (6.3) |
| Squamous cell carcinoma of head and neck | - | 557 (2.2) | 370 (1.9) | 154 (1.6) | 11 (0.8) |
| Breast cancer | 1 (0.6) | 530 (2.1) | 108 (0.6) | 37 (0.4) | 6 (0.4) |
| Cancer of the female reproductive system | 1 (0.6) | 454 (1.8) | 261 (1.4) | 98 (1.0) | 6 (0.4) |
| Haematological malignancy | 31 (17.9) | 722 (2.9) | 335 (1.7) | 172 (1.8) | 26 (1.9) |
| Gastrointestinal tract cancer | 7 (4.0) | 1080 (4.3) | 833 (4.3) | 356 (3.6) | 47 (3.5) |
| Skin cancer | - | 70 (0.3) | 50 (0.3) | 98 (1.0) | 73 (5.4) |
| Cancer of the male reproductive system | - | 104 (0.4) | 142 (0.7) | 86 (0.9) | 15 (1.1) |
| Brain cancer | 18 (10.4) | 225 (0.9) | 84 (0.4) | 18 (0.2) | 3 (0.2) |
| Colon cancer | - | 143 (0.6) | 49 (0.3) | 38 (0.4) | - |
| Sarcoma | 12 (6.9) | 132 (0.5) | 36 (0.2) | 17 (0.2) | 1 (0.1) |
| Thyroid cancer/parathyroid gland cancer | - | 74 (0.3) | 32 (0.2) | 17 (0.2) | 5 (0.4) |
| Mesothelioma | - | 64 (0.3) | 86 (0.4) | 43 (0.4) | 6 (0.4) |
| Neuroendocrine carcinoma | 1 (0.6) | 47 (0.2) | 79 (0.4) | 4 (0) | 8 (0.6) |
| Other ῀ | 1 (0.6) | 305 (1.2) | 231 (1.2) | 139 (1.4) | 13 (1.0) |
| Not reported | 46 (26.6) | 4186 (16.6) | 2629 (13.7) | 1206 (12.3) | 184 (13.7) |
Data are n (%). Abbreviations: ICI, immune checkpoint inhibitor; IQR, interquartile range; CTLA-4, cytotoxic T-lymphocyte antigen-4; PD-1, programmed cell death-1; PD-L1, programmed cell death-ligand1. # Due to ≥2 suspected ICIs with partially recorded or missing dates of administration. ῀ In the five age subgroups. - <18 years: adrenal gland cancer, n = 1. - 18–64 years: adrenal gland cancer, thymoma, n = 34; nasopharyngeal cancer, n = 31; rectal cancer, n = 22; Merkel cell carcinoma, n = 19; bone cancer, n = 18; oral cancer, n = 109; salivary gland cancer, n = 15; peritoneal neoplasm, n = 10; malignant neoplasm of head, face, and neck, n = 8; cardiac neoplasm malignant, n = 3; lipoma, tracheal cancer, n = 1. - 65–74 years: Merkel cell carcinoma, n = 47; oral cancer, n = 70; rectal cancer, n = 20; laryngeal cancer, n = 19; bone cancer, n = 13; peritoneal neoplasm, n = 12; nasopharyngeal cancer, n = 11; tracheal cancer, n = 10; thymoma, n = 8; malignant neoplasm of head, face, and neck, salivary gland cancer, n = 7; adrenal gland cancer, n = 4; cardiac neoplasm malignant, n = 2; ear neoplasm, n = 1. - 75–84 years: Merkel cell carcinoma, n = 71; oral cancer, n = 34; rectal cancer, n = 16; bone cancer, salivary gland cancer, n = 5; peritoneal neoplasm, n = 4; adrenal gland cancer, n = 3; thymoma, n = 1. - ≥ 85 years: oral cancer, n = 7; Merkel cell carcinoma, n = 3; laryngeal cancer, n = 1; nasopharyngeal cancer, thymoma, n = 1.