Table 1.
Cases characteristics.
| Overall |
Narrow irAE |
|
|---|---|---|
| n = 141,630 | n = 50,347 | |
| Sex | ||
| Female | 49,169 (38.5) | 17,810 (38.3) |
| Male | 78,677 (61.5) | 28,717 (61.7) |
| Data available, n (%) | 127,846 (90.2) | 46,527 (92.4) |
| Age (years) | ||
| Mean (SD) | 64 (12.8) | 64.3 (12.6) |
| Age class (years) | ||
| <50 | 13,100 (14.1) | 4798 (13.4) |
| 50–59 | 18,609 (20.0) | 6998 (19.5) |
| 60–69 | 30,803 (33.2) | 11,983 (33.4) |
| 70–79 | 24,022 (25.9) | 9617 (26.8) |
| ≥80 | 6326 (6.8) | 2447 (6.8) |
| Data available, n (%) | 92,860 (65.6) | 35,843 (71.2) |
| Year of first report class | ||
| 2016 or before | 15,569 (11.0) | 4919 (9.8) |
| 2017–2018 | 37,856 (26.7) | 13,889 (27.6) |
| 2018–2019 | 44,661 (31.5) | 17,149 (34.1) |
| 2020–2022 | 43,544 (30.7) | 14,390 (28.6) |
| Clinical triala | ||
| No | 56,671 (64.6) | 25,263 (71.7) |
| Yes | 31,098 (35.4) | 9972 (28.3) |
| Data available, n (%) | 87,769 (62.0) | 35,235 (70.0) |
| Country group | ||
| Eastern Asia | 20,254 (14.3) | 7758 (15.4) |
| Europe | 51,513 (36.4) | 23,350 (46.4) |
| North America | 55,741 (39.4) | 15,743 (31.3) |
| Other country | 14,122 (10.0) | 3496 (6.9) |
| Notifier type | ||
| Physician or pharmacist | 77,978 (56.3) | 32,178 (65.2) |
| Other health professional | 33,046 (23.8) | 11,907 (24.1) |
| Consumer or non-health professional | 27,538 (19.9) | 5287 (10.7) |
| Data available n (%) | 138,562 (97.8) | 49,372 (98.1) |
| Cancer typeb | ||
| Breast | 2521 (2.1) | 758 (1.7) |
| Endometrium | 2308 (1.9) | 591 (1.3) |
| Gastroesophageal | 2662 (2.2) | 671 (1.5) |
| Head & neck | 3962 (3.3) | 1100 (2.5) |
| Liver | 2473 (2.1) | 459 (1.0) |
| Lymphoma | 2075 (1.7) | 685 (1.5) |
| Melanoma | 31,074 (26) | 14,630 (32.8) |
| Non-small cell lung cancer + cytotoxic | 5735 (4.8) | 2117 (4.7) |
| Non-small cell lung cancer w/o cytotoxic | 33,072 (27.7) | 13,280 (29.8) |
| Renal + antiangiogenic | 3411 (2.9) | 1013 (2.3) |
| Renal w/o antiangiogenic | 8532 (7.1) | 3252 (7.3) |
| Small cell lung cancer | 2311 (1.9) | 677 (1.5) |
| Thymus | 139 (0.1) | 71 (0.2) |
| Urothelial & bladder | 5757 (4.8) | 1766 (4.0) |
| Other cancer | 13,981 (11.7) | 3707 (8.3) |
| Data available n (%) | 119,520 (84.4) | 44,589 (88.6) |
| ICI regimen | ||
| Anti-PD1 monotherapy | 91,888 (64.9) | 31,409 (62.4) |
| Anti-CTLA4 monotherapy | 11,176 (7.9) | 4169 (8.3) |
| Anti-PD(L)1+anti-CTLA4 | 17,195 (12.1) | 8215 (16.3) |
| Anti-PDL1 monotherapy | 21,007 (14.8) | 6422 (12.8) |
| Anti-LAG3 combinations | 221 (0.2) | 73 (0.1) |
| Anti-PD1+anti-PDL1 | 143 (0.1) | 59 (0.1) |
| Fatal outcome | 27,786 (19.6) | 5709 (11.3) |
CTLA4: cytotoxic T-lymphocyte–associated antigen 4; ICI: immune checkpoint inhibitors; irAE: immune-related adverse event; LAG3: Lymphocyte-activation gene 3; PD(L)1: programmed death 1 (ligand); SD: standard deviation; w/o: without.
a
Study status was considered as unknown when “unknown” was informed in the study name section of the case report, or when the type of study was doubtful with available information. Of note, all cases from the USA were considered as unknown as USA cases does not report this information to VigiBase.
b
Several cancer types could be reported within the same report, with a total of 142,634 and 50,688 cancer types in the overall and narrow irAE cases, respectively.