Table 1.
Demographic characteristics and distribution for seriousness, outcomes, primary source, primary source country for regulatory purposes, number of suspected drugs other than immune checkpoint inhibitors (ICIs), and number of concomitant drugs of Individual Case Safety Reports (ICSRs) reporting at least one event related to scleroderma and having one ICI as suspected drug among those reported in the EudraVigilance database from the date of marketing authorization to 28 February 2023
| Variable | Level | All ICSRs (n = 70), n (%) |
|---|---|---|
| Age group | 18–64 years | 32 (45.7) |
| 65–85 years | 31 (44.3) | |
| Not specified | 7 (10) | |
| Gender | F | 33 (47.2) |
| M | 36 (51.4) | |
| Missing | 1 (1.4) | |
| Seriousness | Caused/prolonged hospitalization | 14 (20) |
| Disabling | 2 (2.9) | |
| Other medically important conditions | 44 (62.8) | |
| Results in death* | 1 (1.4) | |
| Not reported | 9 (12.9) | |
| Outcome | Recovered/resolved | 7 (10) |
| Recovering/resolving | 18 (25.7) | |
| Not recovered/not resolved | 14 (20) | |
| Fatal* | 1 (1.4) | |
| Unknown | 30 (42.9) | |
| Primary source country for regulatory purposes | European economic area | 40 (57.1) |
| Non-European economic area | 30 (42.9) | |
| Suspected drug(s) other than ICIs | 0 | 63 (90) |
| 1 | 4 (5.7) | |
| 2 | 2 (2.9) | |
| >2 | 1 (1.4) | |
| Concomitant drug(s) | 0 | 58 (82.9) |
| 1 | 1 (1.4) | |
| 2 | 5 (7.1) | |
| 3 | 1 (1.4) | |
| 4 | 2 (2.9) | |
| ≥ 5 | 3 (4.3) |
*This ICSR described a case of scleroderma, immune-mediated dermatitis, immune-mediated lung disease, and tubulointerstitial nephritis that led to patient’s death