Table 2.
Baseline information reported in the 141 160 individual case safety reports (ICSRs) concerning the 15 PKIs in VigiBase®
| Total ICSRs (N = 141 601) | ICSRs with CF (n = 2594) | |
|---|---|---|
| Gender, n (%) | ||
| Female | 64 115 (45.3) | 1166 (45.0) |
| Male | 68 215 (48.2) | 1266 (48.8) |
| Unknown | 9271 (6.6) | 162 (6.3) |
| Age | ||
| mean (SD) | 60.90 (14.81) | 66.26 (13.69) |
| n (%) | ||
| 0–39 | 8835 (5.1) | 63 (2.4) |
| 40–59 | 34 409 (19.9) | 377 (14.5) |
| 60–69 | 29 866 (17.3) | 479 (18.5) |
| 70–80 | 23 076 (13.3) | 530 (20.4) |
| ≥80 | 8066 (4.7) | 260 (10.0) |
| Unknown | 68 724 (39.7) | 885 (34.1) |
| Coadministration of drugs interacting with a PKI, n (%) | 583 (0.4) | 18 (0.7) |
| Coadministration of a drug associated with a risk for CF, n (%) | 26 758 (18.9) | 674 (26.0) |
| Deaths, n (%) | 30 257 (21.4) | 656 (25.3) |
CF, cardiac failure; ICSR, individual case safety report; PKI, protein kinase inhibitor; SD, standard deviation