Table 1. Demographics and clinical characteristics of the individual case safety reports included in the study population.
| Characteristic | n (%), N=6006 |
| Country | |
| Europe* | 4574 (76.2) |
| Asia | 1141 (19.0) |
| Australia | 218 (3.6) |
| South America | 58 (1.0) |
| North America | 13 (0.2) |
| Africa | 2 (0.0) |
| Year | |
| 2011 | 13 (0.2) |
| 2012 | 20 (0.3) |
| 2013 | 22 (0.4) |
| 2014 | 67 (1.1) |
| 2015 | 134 (2.2) |
| 2016 | 461 (7.7) |
| 2017 | 782 (13.0) |
| 2018 | 1067 (17.8) |
| 2019 | 956 (15.9) |
| 2020 | 833 (13.9) |
| 2021 | 863 (14.4) |
| 2022 | 788 (13.1) |
| Reporter | |
| Physician | 4107 (68.4) |
| Pharmacist | 941 (15.7) |
| Other health professional | 811 (13.5) |
| Patient/consumer | 60 (1.0) |
| Lawyer | 1 (0.0) |
| Missing | 86 (1.4) |
| Sex | |
| Male | 3900 (64.9) |
| Female | 2051 (34.2) |
| Missing | 55 (0.9) |
| Age | |
| Reported | 4981 (82.9) |
| Median (IQR), years | 67 (59–74) |
| Missing | 1025 (17.1) |
| Regimen | |
| Anti-CTLA-4 monotherapy | |
| Ipilimumab | 478 (8.0) |
| Anti-PD-1/PD-L1 monotherapy | |
| Nivolumab | 2648 (44.1) |
| Pembrolizumab | 1512 (25.2) |
| Cemiplimab | 82 (1.4) |
| Dostarlimab | 3 (0.1) |
| Atezolizumab | 265 (4.4) |
| Durvalumab | 358 (6.0) |
| Avelumab | 71 (1.2) |
| Anti-PD-1 and anti-CTLA-4 combination | |
| Ipilimumab and nivolumab | 586 (9.8) |
| Ipilimumab and pembrolizumab | 3 (0.1) |
| Indication (in ≥1% of ICSRs) | |
| Lung cancer | 2367 (39.4) |
| Melanoma | 1944 (32.4) |
| Renal cancer | 415 (6.9) |
| Urothelial carcinoma | 130 (2.2) |
| Bronchial cancer | 127 (2.1) |
| Head and neck cancer | 93 (1.6) |
| Mesothelioma | 62 (1.0) |
| Missing | 451 (7.5) |
| Seriousness | |
| Yes | 5111 (85.1) |
| Caused/prolonged hospitalization | 2829 |
| Other medically important condition | 1329 |
| Death | 519 |
| Life threatening | 356 |
| Disabling/incapacitating | 78 |
| No | 830 (13.8) |
| Missing | 65 (1.1) |
*
Out of 4574 ICSRs from Europe, 3618 (79.1%) originated from France (n=1817), Italy (n=837), Germany (n=678) and Spain (n=286).
CTLA-4, cytotoxic T-lymphocyte antigen-4; ICSRs, individual case safety reportsPD-1, programmed cell death-1; PD-L1, programmed cell death-ligand 1