TABLE 3.
Clinical characteristics of patients with immune checkpoint inhibitor-induced aplastic anaemia collected from the FAERS database (January 2011 to June 2022).
| Variables | Nivolumab n = 12 | Pembrolizumab n = 8 | Durvalumab n = 1 | Atezolizumab n = 2 | Avelumab n = 2 | Ipilimumab + nivolumab n = 12 | Atezolizumab + nivolumab n = 1 | Total n = 38 |
|---|---|---|---|---|---|---|---|---|
| Age median (range) | 60 (26–75) n = 7 | 74 (58–81) n = 8 | - | 34 (34–34) n = 1 | 68.5 (68–69) n = 2 | 67 (48–83) n = 10 | 70 (70–70) n = 1 | 68 (26–83) n = 29 |
| Sex | ||||||||
| Male | 2 (16.7) | 2 (25.0) | - | 1 (50.0) | 1 (50.0) | 3 (25.0) | 1 (100.0) | 10 (26.3) |
| Female | 7 (58.3) | 6 (75.0) | - | 1 (50.0) | 1 (50.0) | 7 (58.3) | - | 22 (57.9) |
| Not reported | 3 (25.0) | - | 1 (100.0) | - | - | 2 (16.7) | - | 6 (15.8) |
| Primary source | ||||||||
| Healthcare professional | 11 (91.7) | 6 (75.0) | 1 (100.0) | 2 (100.0) | 2 | 11 (91.7) | - | 33 (86.8) |
| Consumer | 1 (8.3) | 2 (25.0) | - | - | - | 1 (8.3) | 1 (100.0) | 5 (13.2) |
| Outcomes | ||||||||
| Hospitalization | 1 (8.3) | 3 (37.5) | - | - | - | 4 (33.3) | - | 8 (21.1) |
| Life-threatening | 1 (8.3) | 1 (12.5) | - | - | - | 1 (8.3) | - | 3 (7.9) |
| Death | 5 (41.7) | 2 (25.0) | - | 1 (50.0) | - | 5 (41.7) | - | 13 (34.2) |
| Other | 5 (41.7) | 2 (25.0) | 1 (100.0) | 1 (50.0) | 2 (100.0) | 2 (16.7) | 1 (100.0) | 14 (36.8) |
| Reported year | ||||||||
| 2016 | 2 (16.7) | - | - | - | - | 1 (8.3) | - | 3 (7.9) |
| 2017 | 1 (8.3) | - | - | 1 (50.0) | - | - | - | 2 (5.3) |
| 2018 | 5 (41.7) | 1 (12.5) | - | - | - | 6 (50.0) | - | 12 (31.6) |
| 2019 | 2 (16.7) | 1 (12.5) | - | - | - | 2 (16.7) | 1 (100.0) | 6 (15.8) |
| 2020 | - | 2 (25.0) | - | 1 (50.0) | 1 (50.0) | 1 (8.3) | - | 5 (13.2) |
| 2021 | 2 (16.7) | 2 (25.0) | 1 (100.0) | - | 1 (50.0) | - | - | 6 (15.8) |
| 2022 | - | 2 (25.0) | - | - | - | 2 (16.7) | - | 4 (10.5) |
| Source region | ||||||||
| North America | 7 (58.3) | 3 (37.5) | - | 1 (50.0) | - | 6 (50.0) | - | 17 (44.7) |
| Europe | 4 (33.3) | 2 (25.0) | - | 1 (50.0) | 2 (100.0) | 2 (16.7) | 1 (100.0) | 12 (31.6) |
| Asia | 1 (8.3) | 3 (37.5) | 1 (100.0) | - | - | 4 (33.3) | - | 9 (23.7) |
| Indication | ||||||||
| Central nervous system tumor | 3 (25.0) | - | - | - | - | - | - | 3 (7.9) |
| Gastrointestinal cancer | 1 (8.3) | 1 (12.5) | - | - | - | - | - | 2 (5.3) |
| Tumors of the female reproductive organs | - | - | - | 1 (50.0) | - | - | - | 1 (2.6) |
| Hematological cancer and lymphoma | 1 (8.3) | 1 (12.5) | - | - | - | - | - | 2 (5.3) |
| Skin cancer | 3 (25.0) | - | - | - | 1 (50.0) | 6 (50.0) | - | 10 (26.3) |
| Lung cancer | 1 (8.3) | 5 (62.5) | 1 (100.0) | - | - | 5 (41.7) | - | 12 (31.6) |
| Tumors of the urinary system | - | 1 (12.5) | - | - | - | 1 (8.3) | - | 2 (5.3) |
| Unknown or missing | 3 (25.0) | - | - | 1 (50.0) | 1 (50.0) | - | 1 (100.0) | 6 (15.8) |
| Time to onset, days | 36 (36–36) n = 1 | 31.5 (10–510) n = 4 | 101 (101–101) n = 1 | 41 (41–41) n = 1 | 408 (408–408) n = 1 | 12 (11–27) n = 3 | - | 34 (10–510) n = 11 |