Table 3.
Demographic and clinical characteristics of ICI-related irADRs cases and no-irADRs cases sent through the Campania Region spontaneous reporting system from January 2001 to February 2019.
| Variable | Level | All cases, N = 253 (100%) | irADR cases, n = 121 (47.8%) | No-irADRs cases, n = 132 (52.2%) | p-value (< 0.05) |
|---|---|---|---|---|---|
| Age | Median (IQR) | 66 (57–72) | 66 (58–73) | 65.5 (57–71.5) | >0.05* |
| Missing | 9 | 5 | 4 | ||
| Gender | >0.05** | ||||
| Male | 153 (60.5) | 66 (54.5) | 87 (65.9) | ||
| Female | 94 (37.1) | 49 (40.5) | 45 (34.1) | ||
| Missing | 6 (2.4) | 6 (5) | – | ||
| Seriousness of adverse events | 0.001978 | ||||
| Not serious | 176 (69.6) | 72 (59.5) | 104 (78.8) | ||
| Serious | 71 (28) | 45 (37.2) | 26 (19.7) | ||
| NA | 6 (2.4) | 4 (3.3) | 2 (1.5) | ||
| Seriousness criteria | >0.05 | ||||
| Clinically relevant | 52 | 32 (26.4) | 20 (15.2) | ||
| Hospitalization or its prolongation | 15 | 11 (9) | 4 (3) | ||
| Death | 3 | 1 (0.8) | 2 (1) | ||
| Life-threating | 1 | 1 (0.8) | – | ||
| Outcome | >0.05 | ||||
| Favorable (completely resolved or improved) | 154 (60.9) | 71 (58.7) | 83 (62.9) | ||
| Unfavorable (death, unchanged or resolved with sequelae) | 67 (26.5) | 39 (32.2) | 49 (37.1) | ||
| Not available | 32 (12.6) | 11 (9.1) | 21 (15.9) | ||
| Suspected drugs | Nivolumab | 172 (68) | 74 (61.2) | 98 (74.3) | 0.025845 |
| Ipilimumab | 45 (17.8) | 34 (28.1) | 11 (8.3) | 0.00004 | |
| Pembrolizumab | 33 (13) | 12 (9.9) | 21 (15.9) | >0.05 | |
| Atezolizumab | 3 (1.2) | 1 (0.8) | 2 (1.5) | >0.05 | |
* Value of the Mann-Whitney U Test.
** Value of the Fisher exacts test statistic.